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Therapeutic bioequivalency study of brand name versus generic carbamazepine

Department of Neurology, University of Texas Health Science Center, Dallas, TX. (Drs. Oles and Penry)
Office of Research Development, University of Texas Health Science Center, Dallas, TX. (L.D. Smith)
Department of Public Health Sciences, Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, NC Winston-Salem, NC (Dr. Anderson)
Section of Pediatrie Neurology, University of Texas Health Science Center, Dallas, TX. (Dr. Riela)

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 <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 <0.05). Average time to peak was earlier with Epitol. Epitol and Tegretol performed equally well in clinical efficacy and bioequivalency.

Address correspondence and reprint requests to Dr. K.S. Oles, Department of Neurology, Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, NC 27157.

Financial support is acknowledged from Lemmon Co. Support from Ciba-Geigy in the form of drug and placebo is also gratefully acknowledged.

Received August 9, 1991. Accepted for publication in final form November 15, 1991.

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