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A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Fasting Conditions

NCT00864344 · 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. administrated to healthy subjects after a 10-ghour overnight fast

Conditions

  • Healthy

Interventions

DRUG

Sertraline HCl 100 mg tablets, single dose

A: Experimental SSubjects received Purepac formulated products under fasting conditions

DRUG

Zoloft® 100 mg tablets, single dose

B: Active comparator Subjects received Pfizer formulated products under 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 NCT00864344 on ClinicalTrials.gov