NCT01046253

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Lansoprazole	30 mg Delayed-Release Capsules
DRUG	Prevacid®	30 mg Delayed-Release Capsule

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2010-01-11
• Last updated: 2010-12-08
• Results posted: 2010-03-19

Locations

1 site across 1 country: United States