Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers
Status:
Completed
Trial end date:
2019-09-26
Target enrollment:
Participant gender:
Summary
The study was conducted to investigate whether 2 mg cyproterone acetate (CPA) and 0.035 mg
ethinyl estradiol (EE) film-coated tablet (Elzsa®) manufactured by PT. Sydna Farma was
bioequivalent to its reference product, Diane®-35 sugar-coated tablet manufactured by Bayer
Weimar GmbH, Germany, imported by PT. Bayer Indonesia, Depok, Indonesia.