Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers
Not Applicable
Completed
- Conditions
- Drug Use
- Interventions
- Drug: Elzsa film-coated tabletDrug: Diane-35 Sugar-coated tablet
- Registration Number
- NCT04964193
- Lead Sponsor
- PT Sydna Farma
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Elzsa film-coated tablet Elzsa film-coated tablet Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water Diane-35 Sugar-coated tablet Diane-35 Sugar-coated tablet Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water
- Primary Outcome Measures
Name Time Method Pharmacokinetics Parameter before dosing (0 h) and at 15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 15, 24, 36, 48 and 72 hours after dosing Area Under Curve from 0 to 72 hours (AUCt)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PT Pharma Metric Labs
🇮🇩Multiple Locations, Jakarta, Indonesia