Healthy volunteers, A Bioequivalence safety study Bioequivalence Levonorgestrel Tablet 1.50 mg
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Levonorgestrel Tablet 1.50 mg with 250 mL of drinking water.,The marketed original products which were a
Experimental Drug,Active Comparator Drug
Levonorgestrel Tablet 1.50 mg,POSTINOR 1
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 participate in the study. 2. Healthy adult human Thai female participants are between 18 to 55 years of age. 3. The Body Mass Index (BMI) ranges from 18.5 to 30.0 kg/m2. 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to collect approximately 10 mL of blood for the screening processes and approximately 7 mL of blood for monitoring participants safety after the completion of the study. 5. Negative urine pregnancy test 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 Levonorgestrel or any related drugs or any of the excipients of this product. 2. History or evidence of rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. 3. Participant with B.P. is Systolic B.P < 90, >= 140 mm/Hg, Diastolic B.P < 60, >= 90 mm/Hg, pulse rate > 100 beats per minute. 4. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).* 5. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).* 6. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 7. Positive of hepatitis B, C virus. 8. Have more than one abnormal EKG, which is considered as clinically significant. * 9. History or evidence of diabetes mellitus with nephropathy, retinopathy, neuropathy or vascular disease, ischaemic heart disease, stroke, or a past history of breast cancer. 10. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 11. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 12. History of psychiatric disorder. 13. 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. 14. 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. 15. 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. 16. History of grapefruit, pomelo 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. 17. History of St. Johns Wort products consumption and cannot stop at least 7 days before the study drug administration and until the completion of each period of the study. 18. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine, Barbiturate and Opioids). 19. 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. 20. History of difficulty in accessibility of veins in left and right arm. 21. Blood donation (one unit or 450 mL) within the past 3 months before the study. 22. Participation in any clinical study within the past 3 months before the study. 23. Participants who are unwilling or unable to comply with the lifestyle guidelines described in this protocol. (* Depend on decision of principal investigator and/or clinical investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Levonorgestrel level Pre-dose (0.00 hour) & at 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 36.00, 48.00, 60.00, 72.00, 84.00 and 96.00 hours 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) at check-in, pre-dose, at approximately 1.0, 2.0, 4.0, 8.0, 12.0, 24.0, 36.0, 48.0, 60.0, 72.0, 84.0 and 96.0 hours post-dos Automatic blood pressure (Volunteer, Once) | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed