Evaluation of Bioequivalence Between 0.5-mg Dutasteride Capsules Manufactured by GlaxoSmithKline and an Existing Formulation: A Randomized Study in Healthy Japanese Male Volunteers

Clin Pharmacol Drug Dev. 2018 Mar;7(3):341-346. doi: 10.1002/cpdd.407. Epub 2017 Dec 28.

Authors

Hiroko Ino¹, Hiroshi Itoh¹, Yohei Doi¹, Harue Igarashi¹, Yotaro Numachi¹

Affiliation

¹ Development and Medical Affairs Division, GlaxoSmithKline K.K., Tokyo, Japan.

PMID: 29283507
DOI: 10.1002/cpdd.407

No abstract available

Keywords: 5α-reductase inhibitor; benign prostatic hyperplasia; bioequivalence; dutasteride.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

5-alpha Reductase Inhibitors / blood
5-alpha Reductase Inhibitors / chemical synthesis*
5-alpha Reductase Inhibitors / pharmacology*
Adult
Asian People* / genetics
Capsules
Cross-Over Studies
Dose-Response Relationship, Drug
Drug Compounding
Drug Industry / methods*
Dutasteride / blood
Dutasteride / chemical synthesis*
Dutasteride / pharmacology*
Follow-Up Studies
Healthy Volunteers
Humans
Male
Middle Aged
Therapeutic Equivalency
Young Adult

Substances

5-alpha Reductase Inhibitors
Capsules
Dutasteride