Bioinequivalence of a generic brand of diazepam

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Abstract
Twenty‐six healthy male volunteers received a single 10 mg dose of diazepam on two occasions in a crossover bioequivalence study comparing the reference product (Valium) and a generic formulation (NeoCalme). Concentrations of diazepam and its metabolite, desmethyldiazepam, were determined during 264 h after each dose. Peak plasma diazepam concentrations were significantly lower for NeoCalme vs Valium (247 vs 394 ng ml−1, p < 0·001) and reached significantly later after the dose (1·62 vs 0·98 h, p < 0·001). Total area under the plasma concentration curve (AUC) was also significantly lower for NeoCalme (6614 vs 7552 ng ml−1 × h, p < 0·001), although AUC ratios for NeoCalme divided by Valium satisfied the ‘75–75’ guidelines. Findings for desmethyldiazepam were similar. Thus, diazepam absorption from the generic brand of diazepam is significantly slower than from Valium, which in turn could lead to therapeutic inequivalence.

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