Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study

NCT ID: NCT01046253

Last Updated: 2010-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2004-01-31

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 with dosing by applesauce-sprinkle method.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Investigational Test Product

Lansoprazole 30 mg Delayed-Release Capsule

Group Type: EXPERIMENTAL

Lansoprazole

Intervention Type: DRUG

30 mg Delayed-Release Capsules

Reference Listed Drug

Prevacid® 30 mg Delayed-Release Capsule

Group Type: ACTIVE_COMPARATOR

Prevacid®

Intervention Type: DRUG

30 mg Delayed-Release Capsule

Interventions

Lansoprazole

30 mg Delayed-Release Capsules

Intervention Type: DRUG

Prevacid®

30 mg Delayed-Release Capsule

Intervention Type: DRUG

Other Intervention Names

Lansoprazole (generic name)

Eligibility 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 who have taken any investigational drug within 30 days prior to the first dosing of the study 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Ali Ziaee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

B036579

Identifier Type: -

Identifier Source: org_study_id