Status:
COMPLETED
Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations
Lead Sponsor:
University of Ottawa
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
Generic medications should be the equivalent of brand medications with the exception of their price. Before a generic medication is introduced, its bioequivalence within a window of 80 to 125% of the ...
Eligibility Criteria
Inclusion
- Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)
Exclusion
- Psychiatric disorder
- Hepatic disease
- Renal disease
- Gastrointestinal disease
- Hematological disease
- Smokers
- Physical and/or neurological disease
- Positive urine drug screen
- Abnormal blood pressure
- Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00676039
Start Date
November 1 2007
End Date
July 1 2008
Last Update
February 11 2009
Active Locations (1)
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1
University of Ottawa, Institute of Mental Health Research
Ottawa, Ontario, Canada, K1Z7K4