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

Sydna Farma

Status

Completed

Conditions

Drug Use

Treatments

Drug: Elzsa film-coated tablet

Drug: Diane-35 Sugar-coated tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT04964193

440/STD/PML/2018

Details and patient eligibility

About

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.

Full 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

Enrollment

24 patients

Sex

Female

Ages

19 to 54 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.