Therapeutic bioequivalency study of brand name versus generic carbamazepine.

Abstract:

:We performed a randomized double-blind crossover therapeutic bioequivalency study of a generic (Epitol) versus a brand name (Tegretol) carbamazepine product under steady-state conditions in 40 epileptic patients. Each patient received 90-day supplies of Epitol or Tegretol and placebo, which replaced the usual dosage of the alternate product. Group A consisted of 20 seizure-free (from 5 months to 2 years) patients and group B of 20 patients with seizures refractory to drug therapy. In group A, four patients had seizures, two on both Epitol and Tegretol and two on Tegretol. In group B, the average seizure frequencies were 0.25 seizures per day on Epitol and 0.22 seizures per day on Tegretol. Average seizure frequencies were statistically the same (at a 20% difference, p less than 0.05). Areas under the curve were statistically the same (at a 20% difference, p = 0.05). Average peak heights were statistically the same (at a 20% difference, p less than 0.05). Average time to peak was earlier with Epitol. Epitol and Tegretol performed equally well in clinical efficacy and bioequivalency.

journal_name

Neurology

journal_title

Neurology

authors

Oles KS,Penry JK,Smith LD,Anderson RL,Dean JC,Riela AR

doi

10.1212/wnl.42.6.1147

subject

Has Abstract

pub_date

1992-06-01 00:00:00

pages

1147-53

issue

6

eissn

0028-3878

issn

1526-632X

journal_volume

42

pub_type

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