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Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study

2014-08-27 03:16:46 | BioPortfolio

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.

Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Lansoprazole, Lansoprazole

Location

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

Status

Completed

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:46-0400

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Medical and Biotech [MESH] Definitions

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