bioequivalence study of cyproterone acetate and ethinyl estradiol in healthy female volunteers

Conditions: Drug Use

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.

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

Eligibility criteria:
inclusion criteria the inclusion criteria are healthy female subjects who/with: * have read the subject information and signed informed consent documents * age 18 - 55 years * body mass index between 18-25 kg/m2 * have a normal electrocardiogram * blood pressure within normal range (90-120 mmhg for systolic blood pressure and 60-80 mmhg for diastolic blood pressure) * heart rate within normal range (60-100 bpm) * with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening * pass hormone screening related to cyproterone acetate and ethinyl estradiol exclusion criteria any of the following criteria will exclude the subject from the study: * those who are pregnant and/or nursing woman. * those with history of hypersensitivity to cyproterone acetate and ethinyl estradiol or other oral contraception or other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease, allergic reaction, or active allergic. * those with a history or presence medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease. * those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, thrombophlebitis, and thromboembolic disorder. * those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine, oral contraception, anti-platelet drug), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day. * those who have participated in any clinical study within 3 months prior to the study (\< 90 days). * those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study. * those who smoke. * those who are positive to hiv, hbsag, and hcv tests (to be kept confidential). * those with a history of drug or alcohol abuse within 12 months prior to screening for this study. * those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.

Keywords: cyproterone acetate ethinyl estradiol bioequivalence cross-over design study pharmacokinetics indonesian healthy female