PAXIL CR Bioequivalence Study
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Two Single Doses of Controlled Release Paroxetine Given 14 Days Apart; Depressive Disorder; Healthy Volunteer
Intervention: Paxil CR (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
This study is to determine if controlled release paroxetine tablets manufactured at two
different sites behave similarly in healthy volunteers.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Paroxetine blood levels
Secondary outcome: Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Investigational Site, Buffalo, New York 14202, United States
GSK Investigational Site, Tacoma, Washington 98418, United States
Additional Information
Starting date: July 2008
Last updated: October 18, 2012
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