drugset / Trial / NCT01046084
Lansoprazole 30 mg DR Capsule Replicate Food Study
RandomizedCrossoverOpen-label
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.
Timeline
- Start
- 2003-08
- Primary completion
- 2003-09
- Completion
- 2003-09
Outcome
Met primary endpoint
registry Ratio of the T/R geometric mean x 100 103 (90% CI 86.5 to 123) NCT01046084 ↗
registry Ratio of the T/R geometric mean x 100 104 (90% CI 89.3 to 120) NCT01046084 ↗
registry Ratio of the T/R geometric mean x 100 107 (90% CI 92.5 to 123) NCT01046084 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lansoprazole | Other / unclassified | 30 mg | — |
Indications
No indication recorded.