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Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg

NCT00648193 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-04-24

No results posted yet for this study

Summary

The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions to healthy adult volunteers.

Conditions

  • Healthy

Interventions

DRUG

Paroxetine hydrochloride 40 mg tablet

40mg, single dose fasting

DRUG

Paxil® 40 mg Table

40mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Bruce T Czarnik, M.D. · Cetero Research, San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2006-12-31
Completion
2007-01-31

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 NCT00648193 on ClinicalTrials.gov