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Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hachioji-shi, Tokyo, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01699724
Pfizer
Completed
Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

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Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects
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
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: JZoloft
    50 mg tablet on Day 1 of each period
    Other Name: sertraline hydrochloride
  • Drug: sertraline ODT
    50 mg tablet on Day 1 of each period
  • Active Comparator: JZoloft
    Oral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions
    Intervention: Drug: JZoloft
  • Experimental: ODT without water
    sertraline ODT 50 mg without water as a single oral dose under fasted conditions
    Intervention: Drug: sertraline ODT
  • Experimental: ODT with water
    sertraline ODT 50 mg with water as a single oral dose under fasted conditions
    Intervention: Drug: sertraline ODT
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2012
October 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01699724
A0501098
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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