NCT01235195

A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions

Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioequivalence Study Comparing Sertraline Hydrochloride 50 mg Film-Coated Tablets To Sertraline Hydrochloride 50 mg Hard Capsules Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	sertraline hydrochloride	50 mg capsule, single-dose
DRUG	sertraline hydrochloride	50 mg tablet, single-dose

Timeline

• Start date: 2010-11-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-11-05
• Last updated: 2021-01-27
• Results posted: 2012-05-07

Locations

1 site across 1 country: Singapore