Recruiting
Phase 1

Generic vs. Brand

Sponsor:

University of Ottawa

Code:

NCT01400165

Conditions

Healthy

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Trazodone

Quetiapine

Pindolol

Blood Collection

Study Details

Brief summary:

Generic describes a pharmaceutical product that does not have a brand name or trademark. Generic medications should be the equivalent of brand medications. Only their price should be different. The active ingredient of the generic medication has to be within a window of 80 to 125% of the original in the blood. There are reports that this standard is not always followed after the medication has been on the market. Indeed, it was observed that some patients previously stable on original medications relapsed when switched to a generic. Several factors could account for this problem. Such problems have been reported for Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and the original brands will be examined for these three medications. The three original medications used in this study are the Visken, the Seroquel, and the Desyrel. The three generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all available on the Canadian market by prescription.

Conditions

Healthy

Study ID

NCT01400165

Start date

Jul, 2011

Status verified date

Jul, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 50

Healthy Volunteers: Accepted

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 Electrocardiogram
  • Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
  • Taking medication
  • Have donated 50 mL to 499 mL whole blood within 30 days and more than 499 mL whole blood within 56 days preceding entry into this study

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Desyrel/Teva-Trazodone

Both drugs will be given at the dose of 150 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication.

active comparator: Visken/Teva-Pindolol

Both drugs will be given at the dose of 10 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication

active comparator: Seroquel/Teva-Quetiapine

Both drugs will be given at the dose of 100 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication

Interventions

Trazodone

each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)

Quetiapine

each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)

Pindolol

each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)

Blood Collection

Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.

Primary outcome measure

  • Plasma levels of Medication [ Time Frame: 0 to 48 hours after drug ingestion ]

Central Contacts and Locations

Central contacts

Locations

University of Ottawa, Institute of Mental Health Research

Recruiting

Ottawa, Ontario, Canada, K1Z-7K4

Contacts

More Information

Sponsor

University of Ottawa

Last update posted

Jul 22, 2011

Last verified

Jul, 2011

Keywords

  • Therapeutic Equivalency
  • Human Experimentation
  • Bioequivalence
  • Brand name
  • Generic
  • Healthy volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2011-07-22.