PAXIL CR Bioequivalence Study

Verified by: GlaxoSmithKline, January 2012
First Received: September 5, 2008 | Last Updated: January 19, 2012 | Phase: Phase 1 | Start Date: July 2008
Overall Status: Completed | Estimated Enrollment: 166
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This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers...

Brief Summary

Official 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”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
  • Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

  • Drug: Paxil CR
    • Paxil CR 37mg tablet manufactures at two different sites

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: open label treatment

Outcome Measures for this Clinical Trial

Primary Measures

  • Paroxetine blood levels
    • Time Frame: measured up to 168 hours after a single dose.
      Safety Issue?: No

Secondary Measures

  • 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Additional Information

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00749359

Study ID Number: PCR111656

ClinicalTrials.gov Identifier: NCT00749359

Health Authority: United States: Food and Drug Administration

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00749359