Bioequivalence study of an open-label, randomized, two-way crossover design with two-period, two-treatment, two-sequence of test product ethinyl estradiol 0.03 mg/drospirenone 3 mg film-coated tablets and reference product (Yasmin) in healthy Thai female volunteers under fasting conditio
- Conditions
- Healthy volunteers
- Registration Number
- TCTR20181109003
- Lead Sponsor
- Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 32
1)Healthy Thai female subjects based on medical history and physical examination, aged between 18-45 years.
2)Normal or not clinically significant abnormal of clinical laboratory results including blood urea nitrogen (BUN), serum creatinine (SCr), AST, ALT, total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, complete blood count and urinalysis.
3)Clinical laboratory result of hepatitis B is negative.
4)No clinically significant findings in vital sign measurement.
5)Body Mass Index (BMI) between 18.5-25.0 kg/m2 and body weight is not less than 45 kg.
6)Nonsmoker or stop smoking for at least 6 months.
7)Females who participate in this study must:
7.1) be nonpregnant female (negative result for pregnancy test).
7.2) commit to use acceptable non-hormonal contraceptive method of birth control for at least 3 weeks before and during the study as judged by the clinical investigators, such as condoms, non-hormonal intrauterine device (IUD), or willing to remain abstinence (not engage in sexual intercourse) , if there is childbearing potential.
7.3) be not currently breastfeeding.
8) Subjects are able, willing to comply with study procedures and restrictions.
1)Subjects with a history of allergy to ethinyl estradiol and drospirenone or related structures.
2)Subjects with currently or history of alcohol addiction or drug abuse.
3)Subjects with currently or history of severe asthma, lung disease, seizures, gastrointestinal bleeding or ulcer, arrhythmia, hepatic, renal, endocrine, undiagnosed vaginal bleeding, or cardiovascular diseases or any other conditions that may affect bioavailability of the medication studied or safety of the subjects.
4)Subjects who has a suspected venous/arterial thrombosis or has risk to be venous/arterial thrombosis.
5)Subjects who has a presence or history of migraine with focal neurological symptoms.
6)Subjects who use any medications which contain estrogen and/or progesterone within 21 days before and during the study.
7)Subjects who use any medications including vitamins, herbal products, and dietary supplement, within 14 days before and during the study.
8)Subjects who are unable to refrain from consumption of orange, pomelo, grapefruit within 7 days before and during the study.
9)Subjects who are unable to refrain from caffeine-containing beverages and foods such as tea, coffee, cocoa, cola, chocolate or energy drink for 3 days before and during the study.
10)Subjects with positive urine drug abuse test (methamphetamine, cannabinoid and opiates).
11)Subjects with positive alcohol breath test.
12)Subjects with a history of surgery or blood donation greater than 300 ml or significant blood loss within 90 days before the initiation of the study.
13)Subjects with a presence or history prolonged immobilization within 90 days before the initiation of the study.
14)Subjects who participate in other clinical trials within 90 days before the initiation of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ethinyl estradiol concentration in plasma 0.0 - 72.0 h Cmax, AUC0-tlast, AUC0-∞,Drospirenone concentration in plasma 0.0 - 72.0 h Cmax, AUC0-72,Area Under the Plasma Concentration Time Curve From 0-tlast (Ethinyl estradiol) 0.0 - 72.0 h LC-MS/MS,Area Under the Plasma Concentration Time Curve From 0-inf (Ethinyl estradiol) 0.0 - 72.0 h LC-MS/MS,Area Under the Plasma Concentration Time Curve From 0-72h (Drospirenone) 0.0 - 72.0 h LC-MS/MS
- Secondary Outcome Measures
Name Time Method safety at the beginning and at the end of the trial. clinical and laboratory examinations