Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets

Summary

In Brazil, sertraline is currently available as film coated tablets for oral administration containing sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline. The sponsor has developed an oral solution formulation containing 20 mg/mL of sertraline, which must be diluted with 120 mL of water, ginger ale, lime/lemon soda or orange juice to be palatable before use. The purpose of this study is to evaluate the relative bioavailability of Zoloft oral solution compared to Zoloft tablets in healthy participants under fasted conditions.

Timeline

Start

2018-11-06

Primary completion

2019-02-27

Completion

2019-02-27

Drugs

Indications

No indication recorded.