Bioequivalence Study of Sertraline Hydrochloride 100mg Tablets Under Fasting Conditions

NCT00779350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2008-10-24

No results posted yet for this study

Summary

The purpose of this study was to evaluate the relative bioavailability of the test formulation of sertraline 100 mg tablets with an already marketed reference formulation Zoloft® 100 mg tablets (Pfizer), under fasted conditions in healthy male and female adult subjects.

Conditions

  • Healthy

Interventions

DRUG

sertraline 100 mg tablets

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2005-08-31
Completion
2005-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00779350 on ClinicalTrials.gov