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Paxil CR Bioequivalence Study Brazil - Fed Administration

NCT01339247 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-06-20

Study results available
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Summary

The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).

Conditions

  • Depressive Disorder

Interventions

DRUG

Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico

Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

DRUG

Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada

Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-10-20
Primary Completion
2009-11-16
Completion
2009-11-16

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Companies

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 NCT01339247 on ClinicalTrials.gov