NCT01699724

Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Assessing Bioequivalence Of Zoloft ODT 50 Mg Under Fasting Condition With And Without Water To Jzoloft Tablet 50 Mg Under Fasting Condition With Water In Healthy Japanese Subjects

• 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: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition with water in Healthy Japanese Subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JZoloft	50 mg tablet on Day 1 of each period
DRUG	sertraline ODT	50 mg tablet on Day 1 of each period
DRUG	sertraline ODT	50 mg tablet on Day 1 of each period

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-10-04
• Last updated: 2021-01-27

Locations

1 site across 1 country: Japan