Depressive Disorder
Conditions
Keywords
healthy volunteers, paroxetine
Brief summary
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
Interventions
DRUGPaxil CR
Paxil CR 37mg tablet manufactures at two different sites
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Paroxetine blood levels | measured up to 168 hours after a single dose. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed