Trials / Completed
CompletedNCT01046084
Lansoprazole 30 mg DR Capsule Replicate Food Study
A Relative Bioavailability Replicated Crossover Study of Lansoprazole 30 mg Delayed-Release Capsules Under Non-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 non-fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lansoprazole | 30 mg Delayed-Release Capsule |
| DRUG | Prevacid® | 30 mg Delayed-Release Capsule |
Timeline
- Start date
- 2003-08-01
- Primary completion
- 2003-09-01
- Completion
- 2003-09-01
- First posted
- 2010-01-11
- Last updated
- 2010-12-08
- Results posted
- 2010-03-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01046084. Inclusion in this directory is not an endorsement.