Evaluation of Bioequivalence of Five 0.1 mg Dutasteride Capsules Compared to One 0.5 mg Dutasteride Capsule: A Randomized Study in Healthy Male Volunteers

January 2015 in “ Journal of drug assessment ”

Michael J. Fossler, David Collins, Hiroko Ino, Nobuaki Sarai, Ramiya Ravindranath, Chester L. Bowen, Olivia Burns

dutasteride bioequivalence pharmacokinetic parameters Cmax AUC adverse events Avodart

TLDR Taking five small dutasteride capsules is the same as taking one larger capsule.

In a study from 2013-2014 involving 36 healthy male subjects, it was found that taking five 0.1 mg dutasteride capsules is bioequivalent to taking one 0.5 mg dutasteride capsule under fasting conditions. The pharmacokinetic parameters, including maximum concentration (Cmax) and area under the concentration-time curve (AUC), fell within the accepted range for bioequivalence. Adverse events were reported in a similar proportion of subjects for both dosages, with no serious adverse events observed. The study, sponsored by GlaxoSmithKline, concluded that the two dosages can be interchanged and were generally well tolerated.

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Evaluation of Bioequivalence of Five 0.1 mg Dutasteride Capsules Compared to One 0.5 mg Dutasteride Capsule: A Randomized Study in Healthy Male Volunteers

Research cited in this study

research A Randomized, Active- and Placebo-Controlled Study of the Efficacy and Safety of Different Doses of Dutasteride Versus Placebo and Finasteride in the Treatment of Male Subjects with Androgenetic Alopecia

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research Fortnightly Review: Male Pattern Androgenetic Alopecia

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