Lansoprazole 30 mg DR Capsule Fasting Study

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
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 2004
Actual Primary Completion Date :	June 2004
Actual Study Completion Date :	July 2004

Arms and Interventions

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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 Name: Lansoprazole (generic name)

Outcome Measures

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Primary Outcome Measures :

1. Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Blood samples collected over a 12 hour period. ]
   Bioequivalence based on AUC0-inf.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

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Locations

United States, North Dakota
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.

More Information

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ClinicalTrials.gov Identifier:	NCT01045967 History of Changes
Other Study ID Numbers:	B046530
First Posted:	January 11, 2010
Results First Posted:	March 18, 2010
Last Update Posted:	December 8, 2010
Last Verified:	November 2010

Keywords provided by Teva Pharmaceuticals USA:

Bioequivalence; Healthy Subjects

Additional relevant MeSH terms:

Lansoprazole; Dexlansoprazole; Anti-Ulcer Agents; Gastrointestinal Agents	Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action