PAXIL CR Bioequivalence Study
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
1 other identifier
interventional
166
1 country
2
Brief Summary
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2008
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2008
CompletedFirst Submitted
Initial submission to the registry
September 5, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2008
CompletedAugust 4, 2017
August 1, 2017
2 months
September 5, 2008
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Paroxetine blood levels
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
measured up to 168 hours after a single dose and throughout study
Study Arms (1)
open label treatment
EXPERIMENTALOn each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Buffalo, New York, 14202, United States
GSK Investigational Site
Tacoma, Washington, 98418, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2008
First Posted
September 9, 2008
Study Start
July 7, 2008
Primary Completion
September 16, 2008
Study Completion
September 16, 2008
Last Updated
August 4, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.