GSK372475 Bioequivalence Study
Phase 1
Completed
- Conditions
- Healthy SubjectsDepressive Disorder
- Registration Number
- NCT00488098
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- Healthy Males/Females aged 18-45 years
- Non-smokers
- BMI 19-30 kg.m2
- QTc<450msec
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Exclusion Criteria
- Use of oral contraception
- Positive breath alcohol and drug screen
- Regular alcohol consumption
- Current psychiatric illness or within 1 year.
- History of GI, hepatic or renal disease
- Uncontrolled hypertension
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
- Secondary Outcome Measures
Name Time Method Adverse events all visits vitals (all visits) + ECG at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose. labs at screening and 2 weeks post dose
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇦Toronto, Ontario, Canada