The study is conducted in healthy Thai human volunteers (used as combined oral contraceptive pills) Bioequivalence Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg tablets with 250 mL of drinking water and at least 28 day
Experimental Drug,Active Comparator Drug
Drospirenone 3 mg + Ethinyl Estradiol 0.03 mg Tablets ,Yasmin
Sponsors
Bio-innova Co., Ltd.
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to provide written informed consent prior to participating in the study. 2. Healthy Thai female subjects are between 18 to 55 years of age. 3. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2. 4. Comprehensive of the nature and purpose of the study, compliance with the requirements of the entire protocol, and consent to the blood collection by investigators of approximately 10 mL for the screening process and approximately 7 mL for monitoring the subjects safety after the completion of the study. 5. Negative urine pregnancy test for women and no breast-feeding. 6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. complete blood count etc. that out of the normal range will be carefully considered by physician
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Drospirenone, Ethinyl Estradiol, any related drugs, or any of the excipients in this product. 2. Subject with a systolic blood pressure (BP) < 90 or >= 140 mmHg, diastolic BP < 60 or >= 90 mmHg, or a pulse rate > 100 beats per minute. 3. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).* 4. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).* 5. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 6. Positive of hepatitis B or C virus. 7. Have more than one abnormal EKG which is considered clinically significant. * 8. History or evidence of heart disease (heart attack, coronary artery disease), renal impairment, liver disease, adrenal insufficiency, hypertension, vascular disease (deep vein thrombotic, pulmonary embolism, retinal thrombosis), stoke, gallbladder disease, migraine with aura, metabolic disorder 9. History or family history of VTE in a first degree relative under the age of 45. 10. History of abnormal uterine bleeding or coagulopathy. 11. History or family history in a first degree of breast cancer. 12. History or evidence of gastrointestinal (GI) disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 13. Any major illness in the past 3 months or any ongoing chronic medical illness. 14. History of psychiatric disorder or depression. 15. History of regular alcohol consumption exceeding 7 drinks/week for females (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 16. History of regular smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of the study. 17. High caffeine/xanthine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 18. History of pomelo or grapefruit or grapefruit products consumption and cannot stop at least 7 days before the study drug administration and until the completion of each period of the study. 19. History of St. Johns Wort products consumption and cannot stop at least 28 days before the study drug administration and until the completion of the study. 20. Positive drug abuse test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids). 21. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or Over-the-Counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to receiving the first dose of study medication. 22. History of difficulty in accessibility of veins in left and right arm. 23. Blood donation (one unit or 450 mL) within the past 3 months before the study. 24. Participation in any clinical study within the past 3 months before the study. 25. Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this proto
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration, area under the plasma concentration curve from dosing to last observed concentration at time t, area under the plasma concentration curve extrapolated to infinite time pre-dose (0.00 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.00, 48.000 and 72.000 hours post-dose Pharmacokinetics parameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; Adverse events pre-dose, at approximately 1.0, 2.0, 4.0, 12.0, 24.0, 36.0, 48.0, and 72.0 hours post-dose Safety monitoring, vital sign | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed