Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study

A Relative Bioavailability Replicate Sprinkle Study of Lansoprazole 30 mg Delayed-Release Capsules Under Fasting Conditions

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lansoprazole; Drug: Prevacid®

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Gateway Medical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Test Product; Lansoprazole 30 mg Delayed-Release Capsule	Drug: Lansoprazole; 30 mg Delayed-Release Capsules
Active Comparator: Reference Listed Drug; Prevacid® 30 mg Delayed-Release Capsule	Drug: Prevacid®; 30 mg Delayed-Release Capsule; Other Names: Lansoprazole (generic name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)	Bioequivalence based on Cmax.	Blood samples collected over a 12 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	Bioequivalence based on AUC0-t.	Blood samples collected over a 12 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)	Bioequivalence based on AUC0-inf.	Blood samples collected over a 12 hour period.

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Ali Ziaee, M.D., Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): January 1, 2004
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 2010
• Last Update Submitted That Met QC Criteria: November 22, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: B036579