Completed
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
What is being tested
JZoloft
+ sertraline ODT
+ sertraline ODT
Drug
Who is being recruted
From 20 to 55 Years
+4 Eligibility Criteria
How is the trial designed
Basic Science Study
Phase 1
Interventional
Study Start: September 2012
Summary
Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last updated: January 27, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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
Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last updated: January 27, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 20 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs)
Healthy Japanese subjects between the ages of 20 and 55 years
2 exclusion criteria prevent from participating
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
Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk per criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorOral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions
Group II
Experimentalsertraline ODT 50 mg without water as a single oral dose under fasted conditions
Group III
Experimentalsertraline ODT 50 mg with water as a single oral dose under fasted conditions
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center