Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

JZoloftDRUG

50 mg tablet on Day 1 of each period

sertraline ODTDRUG

50 mg tablet on Day 1 of each period

sertraline ODTDRUG

50 mg tablet on Day 1 of each period

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Japanese subjects between the ages of 20 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk per criteria. * Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication and for 28 days after the last dose of study medication.

Locations (1)

Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Outcomes

Primary Outcomes

AUC from zero to the last sampling point (AUCt) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions