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Completed

NCT Number: NCT01699724

Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

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

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JZoloft

Drug

50 mg tablet on Day 1 of each period

Other names: sertraline hydrochloride

sertraline ODT

Drug

50 mg tablet on Day 1 of each period

Primary outcomes

  1. 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

    Time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

  2. Maximum plasma concentration (Cmax) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions

    Time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Secondary outcomes

  1. Cmax and AUCt of sertraline after dose of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions

    Time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

  2. Time of maximum plasma concentration of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions

    Time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

  3. AUC from zero to infinity or last measurable concentration of sertraline after dose of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions

    Time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

  4. Terminal elimination rate constant (kel), half-life (t½) and mean residence time (MRT) of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions

    Time frame: 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

  5. Safety laboratory tests, vital signs, and adverse events (AEs)

    Time frame: From Periods 1 to 3

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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