Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: sertraline ODT; Drug: JZoloft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01699724

A0501098

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

JZoloft

Active Comparator group

Description:

Oral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions

Treatment:

Drug: JZoloft

ODT without water

Experimental group

Description:

sertraline ODT 50 mg without water as a single oral dose under fasted conditions

Treatment:

Drug: sertraline ODT

Drug: sertraline ODT

ODT with water

Experimental group

Description:

sertraline ODT 50 mg with water as a single oral dose under fasted conditions

Treatment:

Drug: sertraline ODT

Drug: sertraline ODT