drugset / Trial / NCT00864019
A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Non-fasting Conditions
RandomizedCrossoverOpen-label
Summary
To compare the rate of absorption and oral bioavailability of a test formulation of Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer Inc. Following an overnight fast of at least 10 hours, subjects will consume a standard high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to each dose.
Timeline
- Start
- 2004-08
- Primary completion
- 2004-08
- Completion
- 2004-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sertraline | Small molecule | 100 mg | Oral |
Indications
No indication recorded.