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Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

NCT01699724 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-01-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01699724 on ClinicalTrials.gov