Lansoprazole 30 mg DR Capsule Fasting Study

• Sponsor: Teva Pharmaceuticals USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01045967
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 27.9

Study Details

Study Description

Brief Summary

The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lansoprazole; Drug: Prevacid®	Phase 1

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Relative Bioavailability Study of Lansoprazole 30 mg DR Capsules Under Fasting Conditions.
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Jun 1, 2004
• Actual Study Completion Date: Jul 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Invesigational Test Product Lansoprazole 30 mg delayed-release Capsules	Drug: Lansoprazole; 30 mg delayed-release Capsule
Active Comparator: Reference Listed Drug Prevacid® 30 mg delayed-release Capsules	Drug: Prevacid®; 30 mg delayed-release Capsule; Other Names: Lansoprazole (generic name)

Outcome Measures

Primary Outcome Measures

1. Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [Blood samples collected over a 12 hour period.]

   Bioequivalence based on Cmax.

2. AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [Blood samples collected over a 12 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 12 hour period.]

   Bioequivalence based on AUC0-inf.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Non-smokers or light smokers (10 or less cigarettes per day)

• 18 years of age or older

• Body Mass Index of 30 or less

• Males or non-pregnant females

• Normal clinical laboratory test results

Exclusion Criteria:

• Subjects with a significant history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.

• Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.

• Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.

• Subjects who are heavy users of tobacco (smoke more than 10 cigarettes a day, smoke cigars or pipes, or use oral tobacco products) will not be eligible to participate in the study. Light smokers may participate, but can not smoke from 2 hours before dosing until 2 hours after dosing.

• Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.

• Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study.

• Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allow to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 180 days of dosing will not be allowed to participate.

• Female subjects with a positive or inconclusive pregnancy test result will be withdrawn from the study.

• Subjects who do not tolerate venipuncture will not be allowed to participate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRACS Institute, Ltd.	Fargo	North Dakota	United States	58104

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: NCT01045967
• Other Study ID Numbers: B046530
• First Posted: Jan 11, 2010
• Last Update Posted: Dec 8, 2010
• Last Verified: Nov 1, 2010

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

Study Results

Participant Flow

Arm/Group Title	Test (Lansoprazole) First	Reference (Prevacid®) First
Arm/Group Description	30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.	30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
Period Title: First Intervention
STARTED	28	28
COMPLETED	28	28
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	28	28
COMPLETED	28	28
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	28	28
COMPLETED	28	27
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Test (Lansoprazole) First	Reference (Prevacid®) First	Total
Arm/Group Description	30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.	30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.	Total of all reporting groups
Overall Participants	28	28	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 100%	28 100%	56 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	12 42.9%	14 50%	26 46.4%
Male	16 57.1%	14 50%	30 53.6%
Race/Ethnicity, Customized (participants) [Number]
White	27 96.4%	27 96.4%	54 96.4%
Asian	1 3.6%	0 0%	1 1.8%
Hispanic	0 0%	1 3.6%	1 1.8%
Region of Enrollment (participants) [Number]
United States	28 100%	28 100%	56 100%

Outcome Measures

1. Primary Outcome

Title	Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Description	Bioequivalence based on Cmax.
Time Frame	Blood samples collected over a 12 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Test (Lansoprazole)	Reference (Prevacid®)
Arm/Group Description	30 mg Lansoprazole DR Capsules test product dosed in either period.	30 mg Prevacid® DR Capsules reference product dosed in either period.
Measure Participants	55	55
Mean (Standard Deviation) [ng/mL]	939.025 (438.28)	865.678 (359.365)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test (Lansoprazole), Reference (Prevacid®)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
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	105
	Confidence Interval	(2-Sided) 90%; 90.7 to 122
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

2. Primary Outcome

Title	AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Description	Bioequivalence based on AUC0-t.
Time Frame	Blood samples collected over a 12 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Test (Lansoprazole)	Reference (Prevacid®)
Arm/Group Description	30 mg Lansoprazole DR Capsules test product dosed in either period.	30 mg Prevacid® DR Capsules reference product dosed in either period.
Measure Participants	55	55
Mean (Standard Deviation) [ng*h/mL]	2156.104 (1746.337)	2130.082 (1486.442)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test (Lansoprazole), Reference (Prevacid®)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
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	97.2
	Confidence Interval	(2-Sided) 90%; 86.1 to 110
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

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 12 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Test (Lansoprazole)	Reference (Prevacid®)
Arm/Group Description	30 mg Lansoprazole DR Capsules test product dosed in either period.	30 mg Prevacid® DR Capsules reference product dosed in either period.
Measure Participants	55	55
Mean (Standard Deviation) [ng*h/mL]	2253.776 (2126.251)	2195.918 (1667.722)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test (Lansoprazole), Reference (Prevacid®)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
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	97.4
	Confidence Interval	(2-Sided) 90%; 86.3 to 110
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.

Adverse Events

Time Frame	Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Adverse Event Reporting Description	Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
Arm/Group Title	Test (Lansoprazole)		Reference (Prevacid®)
Arm/Group Description	30 mg Lansoprazole DR Capsules test product dosed in either period.		30 mg Prevacid® DR Capsules reference product dosed in either period.
All Cause Mortality
	Test (Lansoprazole)		Reference (Prevacid®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Test (Lansoprazole)		Reference (Prevacid®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Test (Lansoprazole)		Reference (Prevacid®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/56 (10.7%)		3/56 (5.4%)
General disorders
Dizziness	3/56 (5.4%)	3	0/56 (0%)	0
Headache	3/56 (5.4%)	3	3/56 (5.4%)	3

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.