Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets
Status:
Completed
Trial end date:
2019-02-27
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Pfizer Pfizer's Upjohn has merged with Mylan to form Viatris Inc.