Bioequivalence Study of 2 mg Dienogest Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Visanne® Tablets Manufactured by Bayer Weimar GmbH und Co. KG, Germany Imported by PT. Bayer Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-E092TGE
Tanggal Input Registry : 17-02-2023

19-07-2022
The primary objective of this study is to establish bioequivalence of 2 mg Dienogest Tablets produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in comparison with Visanne® Tablets Manufactured by Bayer Weimar GmbH und Co. KG, Germany Imported by PT. Bayer Indonesia
Tolerance assessment was not a major objective in this study. However, comparison of tolerance between the two products was a secondary objective. The criteria of safety would include any adverse reactions or significant abnormal laboratory values, or abnormal physical examinations or vital signs measurements recorded during the study. Any of these observations were documented in the subject’s Case Report Form (CRF).
 
Bioequivalence Study of 2 mg Dienogest Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Visanne® Tablets Manufactured by Bayer Weimar GmbH und Co. KG, Germany Imported by PT. Bayer Indonesia
Bioequivalence Study of 2 mg Dienogest Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Visanne® Tablets Manufactured by Bayer Weimar GmbH und Co. KG, Germany Imported by PT. Bayer Indonesia
Interventional
The reference drug was the market available Visanne® Tablet batch number WET75U manufacturing date February 2020, expiration date February 2023. The test drug was Dienogest 2 mg Tablet produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratoirs, batch number EEE316 manufacturing date June 2021 , expiration date June 2023. In the sampling day, each subject received a single-oral dose of 2 mg Dieogest, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for ar least 8 hours. Water intake was allowed except for one hour before and one hour after the dose
22
 

Inclusion Criteria:

Inclusion Criteria 1. Gave a written informed consent. 2. Healthy postmenopausal or surgically sterile(5) female subjects, age between 40 to 60 years old. 3. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2). 4. Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm). 5. Acceptable medical history and physical examination. 6. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR).* 7. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine.* 8. Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria).* 9. Normal cardiovascular function was proven by electrocardiogram (ECG) result. 10. Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine. 12. Negative result for rapid antigen test of COVID-19 (Coronavirus) during COVID-19 pandemic (were done for all subjects at screening, before period I and before period II of the study). 13. Negative result for pregnancy test (will be done screening, before period I and before period II of the study).

Exclusion Criteria:

Exclusion Criteria 1. Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted. 2. Pregnant woman or nursing mother. 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Had active or history of venous thromboembolic disorder. 5. Had active or history of arterial and cardiovascular disease (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease). 6. Had diabetes mellitus with vascular involvement. 7. Had active or history of severe hepatic disease as long as liver function values have not returned to normal. 8. Had active or history of liver tumors (benign or malignant). 9. Had known or suspected sex hormone-dependent malignancies. 10. Had a history or condition of undiagnosed vaginal bleeding. 11. Hypersensitivity to dienogest or to this type of medication. 12. History of alcohol, drug abuse within 12 months prior to screening for this study. 13. Received any other medications within fourteen days prior to the start of the study. 14. Participated in any clinical study within 3 months after the date of completion. 15. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study. 16. Positive result for rapid antigen test of COVID-19 (Coronavirus) at screening, before starting period I or II.
 
KET-755/UN2.F1/ETIK/PPM.00.02/2021 2021-08-02
CCCXI/201/CL/2021
Andre Rafela