Generic and Brand-Name Carbamazepine Are Bioequivalent

Several reports have raised concerns about clinically meaningful differences in serum level, therapeutic effect, and adverse effects between generic and brand-name anticonvulsants. This industry-sponsored crossover study completed by 28 healthy male subjects demonstrates bioequivalence between a generic and brand-name form of carbamazepine.

Following two weeks of open treatment with brand-name carbamazepine (Tegretol), during which the dose was gradually increased to 200 mg three times daily, half the group continued on Tegretol and the other half were switched to generic carbamazepine at the same dose. One week later, subjects were crossed over to the other medication for one week. The two preparations produced similar plasma concentrations…