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OpenTrials
Completed

NCT Number: NCT00749359

PAXIL CR Bioequivalence Study

This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.

Completed

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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Buffalo, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion:

Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG.

Key Exclusion:

Positive test for drugs or alcohol. Positive for Hepatitis or HIV. Any history of psychiatric disorder or suicidal behavior. Has taken another investigational product within 30 days of the start of this study. Has been exposed to more than 4 new chemical entities in the last 12 months. Females who are pregnant or nursing. Regular consumption of alcohol; >14 drinks/week for men or >7 drinks/week for women. Heavy smokers; greater than 20 cigarettes per day.

Treatment and study plan

Paxil CR

Drug

Paxil CR 37mg tablet manufactures at two different sites

Primary outcomes

  1. Paroxetine blood levels

    Time frame: measured up to 168 hours after a single dose.

Secondary outcomes

  1. Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs

    Time frame: measured up to 168 hours after a single dose and throughout study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2008
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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