Diazepam- Roches Valium er best ingen protest

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DIAZEPAM

A crossover study in 26 healthy volunteers compared the hioequivalence of

brand-name and generic diazepam. 36 The formulations were administered as 10

mg on 2 separate occasions, and concentrations of diazepam and its rate of conversion

to desmethyldiazepam were assessed 264 hours after each administration.

There were statistically significant differences in Cmax and AUC in favor of hrandname

diazepam. In particular, the Cmax of the brand-name drug was higher than

that of the generic product (394 vs 247 ng/mL; P , whereas the AUC of

the generic product was significantly lower than that of the brand-name drug (6614 vs 7552 ng/mL-’ per hour; P

were essentially identical for the 2 drugs.

The rate of absorption of the generic

formulation of diazepam appears to he significantly slower than that of the brandname

product, which translates into a lack of therapeutic equivalence.