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A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Non-fasting Conditions

NCT00864019 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-08-16

No results posted yet for this study

Summary

To compare the rate of absorption and oral bioavailability of a test formulation of Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer Inc. Following an overnight fast of at least 10 hours, subjects will consume a standard high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to each dose.

Conditions

  • Healthy

Interventions

DRUG

Sertraline HCl 100 mg tablets, single dose

A: Experimental SSubjects received Purepac formulated products under non-fasting conditions

DRUG

Zoloft® 100 mg tablets, single dose

B: Active comparator Subjects received Pfizer formulated products under non-fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel V. Freeland,, D.O., CCI · CEDRA Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2004-08-31
Completion
2004-08-31

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 NCT00864019 on ClinicalTrials.gov