Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01699724
First received: September 18, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: JZoloft
Drug: sertraline ODT
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety laboratory tests, vital signs, and adverse events (AEs) [ Time Frame: From Periods 1 to 3 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: JZoloft
Oral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions
Drug: JZoloft
50 mg tablet on Day 1 of each period
Other Name: sertraline hydrochloride
Experimental: ODT without water
sertraline ODT 50 mg without water as a single oral dose under fasted conditions
Drug: sertraline ODT
50 mg tablet on Day 1 of each period
Experimental: ODT with water
sertraline ODT 50 mg with water as a single oral dose under fasted conditions
Drug: sertraline ODT
50 mg tablet on Day 1 of each period

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699724

Locations
Japan
Pfizer Investigational Site
Hachioji-shi, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01699724     History of Changes
Other Study ID Numbers: A0501098
Study First Received: September 18, 2012
Last Updated: October 31, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
JZoloft
Sertraline hydrochloride
ODT
bioequivalence

Additional relevant MeSH terms:
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014