Conditions: Drug Use
Keywords: cyproterone acetate ethinyl estradiol bioequivalence cross-over design study pharmacokinetics Indonesian healthy female
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief 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.

Detailed description:
Twenty four healty female subjects were given a single dose of Elzsa® FCT or or Diane®-35 with 240 mL of water. Then the blood samples for CPA and EE were drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Arms:
arm 1: Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water arm 2: Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water

Interventions: intervention 1: Elzsa film-coated tablet intervention 2: Diane-35 Sugar-coated tablet
Intervention descriptions: intervention 1: Administered with 240 mL of water intervention 2: Administered with 240 mL of water

Protocol document:
Prot_SAP_001.pdf: