NCT01235195

Brief Summary

This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 7, 2012

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

November 3, 2010

Results QC Date

November 21, 2011

Last Update Submit

January 25, 2021

Conditions

Healthy

Keywords

bioequivalence studysertraline 50 mgcapsules vs tablets

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]

    AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).

    Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

  • Maximum Observed Plasma Concentration (Cmax)

    Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

Secondary Outcomes (4)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

  • Residual Area Under the Concentration Time Curve [AUC(Res%)]

    Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

  • Plasma Decay Half-Life (t1/2)

    Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose

Study Arms (2)

Sertraline 50 mg capsules

ACTIVE COMPARATOR
Drug: sertraline hydrochloride

Sertraline 50 mg tablet

ACTIVE COMPARATOR
Drug: sertraline hydrochloride

Interventions

sertraline hydrochlorideDRUG

50 mg capsule, single-dose

Also known as: Zoloft
Sertraline 50 mg capsules

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 5, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 27, 2021

Results First Posted

May 7, 2012

Record last verified: 2021-01

Locations

SG(1)