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.

View this study on tandfonline.com →

Discuss this study in the Community →

Research cited in this study

8 / 8 results

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

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

97 citations , January 2014 in “Journal of The American Academy of Dermatology”

Dutasteride 0.5 mg works better than finasteride and placebo for increasing hair in men with hair loss.

research Dutasteride for the Treatment of Benign Prostatic Hyperplasia

24 citations , June 2013 in “Expert opinion on pharmacotherapy”

Dutasteride effectively treats benign prostatic hyperplasia but isn't approved for preventing prostate cancer.

Efficacy, Safety, and Tolerability of Dutasteride 0.5 mg Once Daily in Male Patients with Male Pattern Hair Loss: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study

research Efficacy, Safety, and Tolerability of Dutasteride 0.5 mg Once Daily in Male Patients with Male Pattern Hair Loss: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study

92 citations , June 2010 in “Journal of The American Academy of Dermatology”

Dutasteride 0.5 mg daily improves hair growth safely in men with hair loss.

The Importance of Dual 5α-Reductase Inhibition in the Treatment of Male Pattern Hair Loss: Results of a Randomized Placebo-Controlled Study of Dutasteride Versus Finasteride

research The Importance of Dual 5α-Reductase Inhibition in the Treatment of Male Pattern Hair Loss: Results of a Randomized Placebo-Controlled Study of Dutasteride Versus Finasteride

215 citations , November 2006 in “Journal of The American Academy of Dermatology”

Dutasteride more effective for hair growth, but has more side effects than finasteride.

research Discovery and Clinical Development of Dutasteride, a Potent Dual 5α-Reductase Inhibitor

58 citations , March 2006 in “Current topics in medicinal chemistry”

Dutasteride effectively treats benign prostatic hyperplasia and may reduce prostate cancer risk.

research Fortnightly Review: Male Pattern Androgenetic Alopecia

179 citations , September 1998 in “BMJ”

Hair loss in men is common, treatable, but not curable.

Different Levels of 5α-Reductase Type I and II, Aromatase, and Androgen Receptor in Hair Follicles of Women and Men with Androgenetic Alopecia

research Different Levels of 5α-Reductase Type I and II, Aromatase, and Androgen Receptor in Hair Follicles of Women and Men with Androgenetic Alopecia

416 citations , September 1997 in “Journal of Investigative Dermatology”

People with hair loss have more androgen receptors and enzymes in certain follicles, with men and women showing different patterns.

research Androgen Metabolism as It Affects Hair Growth in Androgenetic Alopecia

143 citations , October 1996 in “Dermatologic Clinics”

Too much androgen can cause hair loss; finasteride may help.