The study is conducted in healthy Thai human volunteers Bioequivalence Dienogest Tablet 2 mg
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Dienogest Tablet 2 mg with 250 mL of drinking water,The marketed original products which were already av
Experimental Drug,Active Comparator Drug
Dienogest Tablet 2 mg,Visanne (original Dienogest Tablet 2 mg)
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 blood collection by investigators of approximately 10 mL for the screening process and approximately 7 mL of blood for monitoring 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 Dienogest or 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 as clinically significant. 8. History or evidence of cardiovascular and vascular diseases (deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, ischemic heart disease), diabetes mellitus with vascular involvement, hepatic diseases, migraine with focal aura, osteoporosis 9. History or family history of venous thromboembolism in the first degree relative under the age of 45. 10. History or family history in the first degree of breast cancer. 11. History or family history in the first degree of liver tumor (benign or malignant) 12. History of abnormal vaginal or uterine bleeding. 13. Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields 14. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 15. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 16. History or evidence of psychiatric disorder. 17. History of regular alcohol consumption exceeding 7 drinks/week (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. 18. History of usual 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 each period of the study. 19. High caffeine/xanthines 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. 20. History of grapefruit or its products consumption and cannot stop at least 7 days before the study drug administration and until the completion of each period of the study. 21. 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. 22. Positive drug abuse test in urine (Marijuana (THC), Cocaine, Opioids, Methamphetamine, Benzodiazepines, and Barbiturates). 23. 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 drug. 24. History of difficulty in accessibility of veins in left and right arm. 25. Blood donation (one unit or 450 mL) within the past 3 months before the study. 26. Part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Dienogest level pre-dose (0.00 hour) and at 0.17, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign (Systolic BP, Diastolic BP, Pulse) 1.0, 2.0, 3.0, 6.0, 12.0, 24.0, 36.0, 48.0, and 72.0 hours Automatic blood pressure (Volunteer, Once) | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed