NCT03711708

Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets

A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF ZOLOFT (REGISTERED) ORAL SOLUTION (20 MG/ML; FARMASIERRA MANUFACTURING, S.L.) COMPARED TO ZOLOFT (REGISTERED) TABLETS (50 MG; WYETH INDÚSTRIA FARMACÊUTICA LTDA.) IN HEALTHY RESEARCH SUBJECTS UNDER FASTED CONDITIONS

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zoloft Oral Solution	Test Product: 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water
DRUG	Zoloft tablets	Reference Product: 50 mg sertraline administered as 1x Zoloft 50 mg tablet

Timeline

• Start date: 2018-11-06
• Primary completion: 2019-02-27
• Completion: 2019-02-27
• First posted: 2018-10-18
• Last updated: 2021-01-27

Locations

1 site across 1 country: Brazil