Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

• Sponsor: Teva Pharmaceuticals USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00835276
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd. with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Fexofenadine 180 mg tablets; Drug: ALLEGRA® 180 mg tablets	Phase 1

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Relative Bioavailability Study of 180 mg Fexofenadine Hydrochloride Tablets Under Fasting Conditions.
• Study Start Date: Mar 1, 2002
• Actual Primary Completion Date: Mar 1, 2002
• Actual Study Completion Date: Mar 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Fexofenadine 180 mg tablets; 1 x 180 mg
Active Comparator: 2	Drug: ALLEGRA® 180 mg tablets; 1 x 180 mg

Outcome Measures

Primary Outcome Measures

1. Cmax = Maximum Observed Concentration. [Blood samples collected over a 48 hour period.]

   Bioequivalence based on Cmax.

2. AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant) [Blood samples collected over a 48 hour period.]

   Bioequivalence based on AUC0-t.

3. AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. [Blood samples collected over a 48 hour period.]

   Bioequivalence based on AUC0-inf.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• All volunteers selected for this study will be healthy, non-smoking men and women 18 to 55 years of age, inclusive, at the time of dosing. The volunteer's body mass index (BMI) is less that or equal to 30.

• If female and :

• of child bearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or

• is postmenopausal for at least 1 year; or

• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

• Volunteers with a recent history of drug or alcohol addiction or abuse.

• Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).

• Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.

• Volunteers demonstration a positive hepatitis B surface antigen screen, hepatitis C antibody screen or a reactive HIV antibody screen.

• Volunteers demonstrating a positive drug abuse screen when screened for this study.

• Female volunteers who are currently breast feeding.

• Female volunteers who are demonstrating a positive pregnancy screen.

• Volunteers with a history of allergic response(s) to fexofenadine or related drugs.

• Volunteers with a history of clinically significant allergies including drug allergies.

• Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).

• Volunteers who currently use or reports using tobacco or nicotine-containing products within 90 days prior to Period I dosing.

• Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.

• Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will by advised not to donate blood for four weeks after completing the study.

• Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.

• Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.

• Volunteers who report taking any prescription medication in the 14 days prior to Period I dosing, with the exception of topical products without systemic absorption.

• Volunteers who have been on an abnormal diet during the 28 days prior to Period I dosing.

• Volunteers who report an intolerance of direct venipuncture.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRACS Institute, Ltd.	Fargo	North Dakota	United States	58102

Sponsors and Collaborators

• Teva Pharmaceuticals USA

Investigators

• Principal Investigator: James D Carlson, Pharm. D., PRACS Institute, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00835276
• Other Study ID Numbers: R01-861
• First Posted: Feb 3, 2009
• Last Update Posted: Aug 20, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Bioequivalence; Healthy Subjects
• Additional relevant MeSH terms: Fexofenadine

Study Results

Participant Flow

Arm/Group Title	Fexofenadine Hydrochloride First	Allegra® First
Arm/Group Description	180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.	180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
Period Title: First Intervention
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Fexofenadine Hydrochloride First	Allegra® First	Total
Arm/Group Description	180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.	180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.	Total of all reporting groups
Overall Participants	24	24	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 100%	24 100%	48 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	6 25%	11 45.8%	17 35.4%
Male	18 75%	13 54.2%	31 64.6%
Race/Ethnicity, Customized (participants) [Number]
American Indian	1 4.2%	0 0%	1 2.1%
White	22 91.7%	24 100%	46 95.8%
Hispanic	1 4.2%	0 0%	1 2.1%
Region of Enrollment (participants) [Number]
United States	24 100%	24 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Cmax = Maximum Observed Concentration.
Description	Bioequivalence based on Cmax.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Fexofenadine Hydrochloride	Allegra®
Arm/Group Description	180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.	180 mg Allegra® Tablets reference product dosed in either period.
Measure Participants	48	48
Mean (Standard Deviation) [ng/mL]	449.6 (216.08)	498.95 (204.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fexofenadine Hydrochloride, Allegra®
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	87.96
	Confidence Interval	() 90%; 80.15 to 96.53
	Parameter Dispersion	Type: Value:
	Estimation Comments	To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.

2. Primary Outcome

Title	AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)
Description	Bioequivalence based on AUC0-t.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Fexofenadine Hydrochloride	Allegra®
Arm/Group Description	180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.	180 mg Allegra® Tablets reference product dosed in either period.
Measure Participants	48	48
Mean (Standard Deviation) [ng*h/mL]	2711.8 (1118.2)	2912.63 (1092.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fexofenadine Hydrochloride, Allegra®
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	91.47
	Confidence Interval	() 90%; 85.15 to 98.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	To establish bioequivalence, the mean values for the test product differ by no more that 20% from the repective mean values for the reference listed product.

3. Primary Outcome

Title	AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
Description	Bioequivalence based on AUC0-inf.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Fexofenadine Hydrochloride	Allegra®
Arm/Group Description	180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.	180 mg Allegra® Tablets reference product dosed in either period.
Measure Participants	48	48
Mean (Standard Deviation) [ng*h/mL]	2814.79 (1132.18)	3024.53 (1104.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fexofenadine Hydrochloride, Allegra®
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	91.47
	Confidence Interval	() 90%; 85.32 to 98.07
	Parameter Dispersion	Type: Value:
	Estimation Comments	To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Principal Investigator is not permitted to discuss or publish trial results.