Bioinequivalence of a generic brand of diazepam.

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 264h after each dose. Peak plasma diazepam concentrations were significantly lower for NeoCalme vs Valium (247 vs 394 ng ml-1, p less than 0.001) and reached significantly later after the dose (1.62 vs 0.98 h, p less than 0.001). Total area under the plasma concentration curve (AUC) was also significantly lower for NeoCalme (6614 vs 7552 ng ml-1 x h, p less than 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.

journal_name

Biopharm Drug Dispos

authors

Locniskar A,Greenblatt DJ,Harmatz JS,Shader RI

doi

10.1002/bdd.2510100609

subject

Has Abstract

pub_date

1989-11-01 00:00:00

pages

597-605

issue

6

eissn

0142-2782

issn

1099-081X

journal_volume

10

pub_type

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