Trials / Completed
CompletedNCT04964193
Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers
Bioequivalence Study of 2 mg Cyproterone Acetate and 0.035 mg Ethinyl Estradiol in Indonesian Healthy Females
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- PT Sydna Farma · Industry
- Sex
- Female
- Age
- 19 Years – 54 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elzsa film-coated tablet | Administered with 240 mL of water |
| DRUG | Diane-35 Sugar-coated tablet | Administered with 240 mL of water |
Timeline
- Start date
- 2019-03-12
- Primary completion
- 2019-07-04
- Completion
- 2019-09-26
- First posted
- 2021-07-16
- Last updated
- 2022-01-31
- Results posted
- 2022-01-31
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04964193. Inclusion in this directory is not an endorsement.