This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01286454
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 6
• Duration (Months): 3
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency	Drug: fesoterodine; Drug: fesoterodine; Drug: fesoterodine; Drug: fesoterodine; Drug: fesoterodine; Drug: fesoterodine	Phase 1

Detailed Description

To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: An Open-Label, Single-Dose, Randomized, Cross-Over Study To Estimate The Bioavailability And Food Effect Of 4 Mg Fesoterodine Extended Release Beads-In-Capsule Formulations Compared To Commercial Tablet Formulation In Healthy Volunteers
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 4 mg fesoterodine IR beads in capsule under fasting condition	Drug: fesoterodine; single dose of beads in capsule
Experimental: B 4 mg fesoterodine 10% coated ER beads in capsule under fasting condition	Drug: fesoterodine; single dose of beads in capsule
Experimental: C 4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.	Drug: fesoterodine; single dose of beads in capsule
Experimental: D 4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.	Drug: fesoterodine; single dose of beads in capsule
Experimental: E 4 mg fesoterodine ER tablets under fasting condition.	Drug: fesoterodine; single dose of tablet
Experimental: F 4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.	Drug: fesoterodine; single dose of beads in capsule

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT]) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose]

   AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.

3. Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose]

Secondary Outcome Measures

1. Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose]

2. Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT) [0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 18 and 55 years

Exclusion Criteria:

• Evidence or history of clinically significant disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01286454
• Other Study ID Numbers: A0221068
• First Posted: Jan 31, 2011
• Last Update Posted: Jan 26, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Pfizer: BIOAVAILABILITY; FOOD EFFECT
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Arm/Group Title	Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER	Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet	Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR	Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER	Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER	Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER	Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER	Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet	Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR	Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER	Fesoterodine 4 mg 10% ER Fed
Arm/Group Description	Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	2	2	2	2	2	2	2	2	2	2	0
COMPLETED	2	2	2	2	2	2	2	2	2	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part I- First Intervention Period
STARTED	0	0	0	0	0	0	0	0	0	0	20
COMPLETED	0	0	0	0	0	0	0	0	0	0	20
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.5 (10.8)
Sex: Female, Male (Count of Participants)
Female	7 35%
Male	13 65%

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
Description	AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.

Arm/Group Title	Fesoterodine 4 mg IR-BIC Fasted	Fesoterodine 4 mg 10% ER-BIC Fasted	Fesoterodine 4 mg 15% ER-BIC Fasted	Fesoterodine 4 mg 20% ER-BIC Fasted	Fesoterodine 4 mg ER Tablet Fasted	Fesoterodine 4 mg 10% ER-BIC Fed
Arm/Group Description	Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Measure Participants	20	20	16	4	20	20
Geometric Mean (Standard Deviation) [ng*hr/mL]	30.48 (11.77)	28.24 (10.35)	19.64 (7.58)	NA (NA)	27.40 (10.06)	32.07 (13.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg IR-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	111.23
	Confidence Interval	(2-Sided) 90%; 102.69 to 120.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	103.07
	Confidence Interval	(2-Sided) 90%; 95.16 to 111.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 15% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	70.36
	Confidence Interval	(2-Sided) 90%; 64.52 to 76.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg 10% ER-BIC Fed
	Comments	Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	113.55
	Confidence Interval	(2-Sided) 90%; 105.91 to 121.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
Time Frame	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Fesoterodine 4 mg IR-BIC Fasted	Fesoterodine 4 mg 10% ER-BIC Fasted	Fesoterodine 4 mg 15% ER-BIC Fasted	Fesoterodine 4 mg 20% ER-BIC Fasted	Fesoterodine 4 mg ER Tablet Fasted	Fesoterodine 4 mg 10% ER-BIC Fed
Arm/Group Description	Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Measure Participants	20	20	20	20	20	20
Geometric Mean (Standard Deviation) [ng*hr/mL]	30.23 (11.79)	27.79 (10.21)	17.92 (6.95)	7.59 (3.57)	26.80 (10.07)	31.88 (13.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg IR-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	112.80
	Confidence Interval	(2-Sided) 90%; 103.85 to 122.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	103.71
	Confidence Interval	(2-Sided) 90%; 95.48 to 112.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 15% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	66.87
	Confidence Interval	(2-Sided) 90%; 61.56 to 72.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 20% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	28.34
	Confidence Interval	(2-Sided) 90%; 26.09 to 30.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg 10% ER-BIC Fed
	Comments	Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	114.70
	Confidence Interval	(2-Sided) 90%; 106.99 to 122.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Time Frame	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Fesoterodine 4 mg IR-BIC Fasted	Fesoterodine 4 mg 10% ER-BIC Fasted	Fesoterodine 4 mg 15% ER-BIC Fasted	Fesoterodine 4 mg 20% ER-BIC Fasted	Fesoterodine 4 mg ER Tablet Fasted	Fesoterodine 4 mg 10% ER-BIC Fed
Arm/Group Description	Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Measure Participants	20	20	20	20	20	20
Geometric Mean (Standard Deviation) [ng/mL]	5.830 (2.729)	3.030 (1.068)	1.092 (0.496)	0.323 (0.183)	2.247 (1.000)	5.183 (1.919)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg IR-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	259.40
	Confidence Interval	(2-Sided) 90%; 231.48 to 290.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	134.83
	Confidence Interval	(2-Sided) 90%; 120.31 to 151.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 15% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	48.58
	Confidence Interval	(2-Sided) 90%; 43.35 to 54.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 20% ER-BIC Fasted, Fesoterodine 4 mg ER Tablet Fasted
	Comments	Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	14.38
	Confidence Interval	(2-Sided) 90%; 12.83 to 16.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 mg 10% ER-BIC Fasted, Fesoterodine 4 mg 10% ER-BIC Fed
	Comments	Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of Adjusted Means
	Estimated Value	171.06
	Confidence Interval	(2-Sided) 90%; 115.82 to 187.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)
Time Frame	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Fesoterodine 4 mg IR-BIC Fasted	Fesoterodine 4 mg 10% ER-BIC Fasted	Fesoterodine 4 mg 15% ER-BIC Fasted	Fesoterodine 4 mg 20% ER-BIC Fasted	Fesoterodine 4 mg ER Tablet Fasted	Fesoterodine 4 mg 10% ER-BIC Fed
Arm/Group Description	Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Measure Participants	20	20	20	20	20	20
Median (Full Range) [hr]	1.0	6.0	6.0	8.0	5.0	4.0

5. Secondary Outcome

Title	Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.

Arm/Group Title	Fesoterodine 4 mg IR-BIC Fasted	Fesoterodine 4 mg 10% ER-BIC Fasted	Fesoterodine 4 mg 15% ER-BIC Fasted	Fesoterodine 4 mg 20% ER-BIC Fasted	Fesoterodine 4 mg ER Tablet Fasted	Fesoterodine 4 mg 10% ER-BIC Fed
Arm/Group Description	Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.	Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
Measure Participants	20	20	16	4	20	20
Mean (Standard Deviation) [hr]	5.56 (1.70)	7.22 (1.68)	10.89 (4.45)	NA (NA)	7.54 (2.49)	4.59 (0.76)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Fesoterodine 4 mg IR-BIC Fasted		Fesoterodine 4 mg 10% ER-BIC Fasted		Fesoterodine 4 mg 15% ER-BIC Fasted		Fesoterodine 4 mg 20% ER-BIC Fasted		Fesoterodine 4 mg ER Tablet Fasted		Fesoterodine 4 mg 10% ER-BIC Fed
Arm/Group Description	Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.		Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.		Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.		Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.		Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.		Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
All Cause Mortality
	Fesoterodine 4 mg IR-BIC Fasted		Fesoterodine 4 mg 10% ER-BIC Fasted		Fesoterodine 4 mg 15% ER-BIC Fasted		Fesoterodine 4 mg 20% ER-BIC Fasted		Fesoterodine 4 mg ER Tablet Fasted		Fesoterodine 4 mg 10% ER-BIC Fed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fesoterodine 4 mg IR-BIC Fasted		Fesoterodine 4 mg 10% ER-BIC Fasted		Fesoterodine 4 mg 15% ER-BIC Fasted		Fesoterodine 4 mg 20% ER-BIC Fasted		Fesoterodine 4 mg ER Tablet Fasted		Fesoterodine 4 mg 10% ER-BIC Fed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Fesoterodine 4 mg IR-BIC Fasted		Fesoterodine 4 mg 10% ER-BIC Fasted		Fesoterodine 4 mg 15% ER-BIC Fasted		Fesoterodine 4 mg 20% ER-BIC Fasted		Fesoterodine 4 mg ER Tablet Fasted		Fesoterodine 4 mg 10% ER-BIC Fed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/20 (35%)		4/20 (20%)		6/20 (30%)		0/20 (0%)		4/20 (20%)		6/20 (30%)
Gastrointestinal disorders
Diarrhoea	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
Dry mouth	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Nausea	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
General disorders
Feeling cold	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Vessel puncture site haematoma	1/20 (5%)		1/20 (5%)		1/20 (5%)		0/20 (0%)		1/20 (5%)		0/20 (0%)
Vessel puncture site pain	1/20 (5%)		1/20 (5%)		1/20 (5%)		0/20 (0%)		1/20 (5%)		1/20 (5%)
Infections and infestations
Viral infection	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
Viral upper respiratory tract infection	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		1/20 (5%)
Musculoskeletal and connective tissue disorders
Back pain	2/20 (10%)		1/20 (5%)		3/20 (15%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Nervous system disorders
Headache	1/20 (5%)		1/20 (5%)		1/20 (5%)		0/20 (0%)		0/20 (0%)		2/20 (10%)
Psychiatric disorders
Insomnia	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/20 (5%)		0/20 (0%)		2/20 (10%)		0/20 (0%)		1/20 (5%)		3/20 (15%)
Skin and subcutaneous tissue disorders
Pruritis	0/20 (0%)		0/20 (0%)		1/20 (5%)		0/20 (0%)		1/20 (5%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.