Not Specified

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
Not Specified
No Registry
INA-1KCBPX7T
Tanggal Input Registry : 16-12-2024

11-11-2022
Not Specified
 
Not Specified
Bioequivalence Study of 0,75 mg Levonorgestrel (Nogestat®) Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Postinor-2® 0,75 mg Tablets Manufactured by Gedeon Richter Plc., Hungary, Imported by PT. Tunggal Idaman Abadi, Indonesia
Observational
38
 

Inclusion Criteria:

1. Providing written consent. 2. Healthy subjects, female, aged between 18 and 55 years. 3. Body weight within the normal range of Body Mass Index (BMI = 18-25 kg/m2). 4. Acceptable normal blood pressure values: - Systolic blood pressure 90 mmHg - Diastolic blood pressure 60 mmHg) - Heart rate (60-90 bpm). 5. Acceptable medical history and physical examination. 6. Normal hematology values ​​include: hemoglobin, hematocrit, erythrocytes, leukocytes, mean corpuscular value (MC), leukocyte differential, platelet count and erythrocyte sedimentation rate (ESR).* 7. Normal laboratory tests include: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, urea, creatinine.* 8. Normal urinalysis results include: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, ketones, urobilinogen, bilirubin, blood and urine sediment (cells, casts, and bacteria).* 9. Normal cardiovascular function is evidenced by electrocardiogram (ECG) results. 10. Negative results for serology tests for hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. Negative results for amphetamine, methamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine drug abuse tests. 12. Negative pregnancy test results (will be screened, before study period I, before study period II and before study period III). 13. Negative COVID-19 (Coronavirus) rapid antigen test results during the COVID-19 pandemic (performed for all subjects at the time of screening). 14. Willing to use contraception (except oral contraceptives or implants) during sexual intercourse to avoid pregnancy. Note: The clinical investigator may include subjects who have values ​​outside the accepted range, if in his/her opinion, these values ​​are not clinically significant.

Exclusion Criteria:

1. Smokers. If necessary, light smokers (≤ 5 cigarettes/day) are acceptable. 2. Using oral contraceptives or implants. 3. Having a history of liver, cardiovascular, gastrointestinal or kidney disease. 4. Having severe liver dysfunction. 5. Having severe malabsorption syndrome, such as Crohn's disease. 6. Having a history of salpingitis or ectopic pregnancy. 7. Having a history of vaginal bleeding of unknown origin, gestational jaundice, thrombophlebitis of breast, ovarian or uterine carcinoma or thromboembolic disorders. 8. Having a history of deep vein thrombophlebitis or thromboembolic disorders, cerebral or coronary artery disease, neoplasm, or undiagnosed abnormal genital bleeding. 9. History of alcohol, drug abuse within 12 months prior to screening for this study. 10. Receiving other medications within fourteen days prior to the start of the study. 11. Participating in any clinical study within 3 months of the completion date. 12. Donation or loss of more than 300 ml of blood within 3 months before the research examination. 13. Hypersensitivity to levonorgestrel or similar drugs. 14. Known or suspected pregnancy. 15. Breastfeeding women.
 
S-542/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
Not Specified