Influence of Alcohol on the Pharmacokinetics of Diazepam Controlled‐Release Formulation in Healthy Volunteers

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Abstract
Twelve normal volunteers were empanelled in an open-label, three-way crossover study to evaluate the influence of alcohol on the pharmacokinetics of controlled-release diazepam capsules. Each volunteer received one 15-mg diazepam controlled-release capsule alone, concomitantly with alcohol or followed by alcohol 2 hours later. The mean plasma concentration—time profiles following both alcohol treatments were superimposable on the profile from the control. The mean plateau concentrations were observed to endure from 2 through 12 hours in all cases. The mean ± S.D. areas under the plasma concentration—time curves from time zero to infinity were similar indicating no difference in the extent of absorption of diazepam in the presence of alcohol. The harmonic mean elimination half-lives were also similar. Overall, the pharmacokinetics and the release properties of control led-release diazepam capsule were not influenced by alcohol in normal volunteers.

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