PAXIL CR Bioequivalence Study

Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749359
• Other study ID #: PCR111656
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2008
• Last updated: August 2, 2017
• Start date: July 7, 2008
• Est. completion date: September 16, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 16, 2008
• Est. primary completion date: September 16, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paroxetine blood levels		measured up to 168 hours after a single dose.
Secondary	Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs		measured up to 168 hours after a single dose and throughout study

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study PCR111656 can be found on the GSK Clinical Study Register.