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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Crossover Effexor / NOVO-Venlafaxine

Examination of the bioequivalence of Effexor (Wyeth Pharmaceuticals) and NOVO-Venlafaxine (NOVOPHARM).

Both drugs will be given at the dose of 75 mg/day (one capsule per day) for 4 consecutive days. A washout period (corresponding to 10 half-life of the active metabolite desmethylvenlafaxine) will be respected after receiving each medication.

Group Type ACTIVE_COMPARATOR

Venlafaxine

Intervention Type DRUG

NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)

Effexor XR

Intervention Type DRUG

Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)

2

Crossover Celexa/Gen-citalopram

Examination of the bioequivalence of Celexa (Lundbeck, Brand Name) and Gen-Citalopram (Genpharm, Generic). Both drugs will be given at the dose of 40 mg/day (one tablet per day) for 8 consecutive days. A washout period (corresponding to 10 half-life of citalopram) will be respected after receiving each medication.

Group Type ACTIVE_COMPARATOR

Gen-Citalopram

Intervention Type DRUG

Gen-Citalopram 40 mg (Genpharm, Generic)

Celexa

Intervention Type DRUG

Celexa 40 mg (Lundbeck, Brand Name)

Interventions

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Venlafaxine

NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic)

Intervention Type DRUG

Gen-Citalopram

Gen-Citalopram 40 mg (Genpharm, Generic)

Intervention Type DRUG

Effexor XR

Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name)

Intervention Type DRUG

Celexa

Celexa 40 mg (Lundbeck, Brand Name)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes