Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Male

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 original has to be demonstrated. There are reports that this criterion is not always followed in post-marketed periods. Such investigations were triggered by the observation that some patients previously stable on original medications relapsed when switched to a presumable equivalent generic. Several factors could account for this problem. Given reports of such problems occurring with the antidepressants citalopram and venlafaxine, some pharmacokinetic properties of specific brands of generics and the originals will be examined for these two medications. Twelve healthy male volunteers will participate in this crossover study. It is anticipated that there will be significant differences emerging between the two formulations given the clinical reports of patients deteriorating when switched from the original to the generic preparations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Ottawa
• Treatments: Antidepressive Agents; Citalopram; Dexetimide; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

Exclusion Criteria:

• 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)