Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 56
Healthy volunteers: yes

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.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms:
arm 1: Lansoprazole 30 mg delayed-release Capsules arm 2: Prevacid® 30 mg delayed-release Capsules

Interventions: intervention 1: Lansoprazole intervention 2: Prevacid®
Intervention descriptions: intervention 1: 30 mg delayed-release Capsule intervention 2: 30 mg delayed-release Capsule

Protocol document: