Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Paroxetine blood levels
Timeframe: measured up to 168 hours after a single dose.
Secondary outcomes:
Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs
Timeframe: measured up to 168 hours after a single dose and throughout study
Interventions:
Drug: Paxil CR
Enrollment:
166
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
July 2008 to September 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Key Inclusion:
- Healthy males or females between 18-65.
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Location
GSK Investigational Site
Buffalo, New York, United States, 14202
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98418
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-16-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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