Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers

Study Overview
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Brief Summary
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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
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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

Official Title
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Bioequivalence Study of 2 mg Cyproterone Acetate and 0.035 mg Ethinyl Estradiol in Indonesian Healthy Females

Conditions
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Drug Use

Intervention / Treatment
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* Drug: Elzsa film-coated tablet
* Drug: Diane-35 Sugar-coated tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, single blind, two-period, single dose, crossover study with three weeks washout period in 24 healthy female subjects under fasting condition.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elzsa film-coated tablet<br>Participants received Elzsa film-coated tablet (2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water | Drug: Elzsa film-coated tablet<br>* Administered with 240 mL of water<br>* Other names: 2 mg cyproterone acetate + 0.035 mg ethinylestradiol;|
| Active Comparator: Diane-35 Sugar-coated tablet<br>Participants received Diane-35 Sugar-coated tablet ( 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) with 240 mL of water | Drug: Diane-35 Sugar-coated tablet<br>* Administered with 240 mL of water<br>* Other names: 2 mg cyproterone acetate + 0.035 mg ethinylestradiol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics Parameter | Maximum plasma concentration (Cmax) | 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 | 
| Pharmacokinetics Parameter | Area Under Curve from 0 to 72 hours (AUCt) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cyproterone acetate, ethinyl estradiol, bioequivalence, cross-over design study, pharmacokinetics, Indonesian healthy female