Bioequivalence Study of 10 mg Isosorbide Dinitrate Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Cedocard® 10 mg Tablets Manufactured and Marketed by PT. Darya-Varia Laboratoria Tbk, Indonesia, Under License From Takeda Netherland bv, The Netherlands

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-TNWH59R
Tanggal Input Registry : 01-08-2024

28-02-2024
AUC0-t , AUC0-inf , Cmax
Tmax, t1/2
 
Bioequivalence Study of 10 mg Isosorbide Dinitrate Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Cedocard® 10 mg Tablets Manufactured and Marketed by PT. Darya-Varia Laboratoria Tbk, Indonesia, Under License From Takeda Netherland bv, The Netherlands
Bioequivalence Study of 10 mg Isosorbide Dinitrate Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Cedocard® 10 mg Tablets Manufactured and Marketed by PT. Darya-Varia Laboratoria Tbk, Indonesia, Under License From Takeda Netherland bv, The Netherlands
Interventional
Isosorbide DinitrateTablet 10 mg manufactured by PT Novell Pharmaceutical Laboratories
24
 

Inclusion Criteria:

1. Gave a written informed consent. 2. Healthy subjects, both sexes, age between 18 to 55 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 70 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 pregnancy test (was done for female subjects at screening, before period I and before period II of the study). 13. Subject had either received COVID-19 (Coronavirus) vaccine minimum of first booster or negative result for COVID-19 rapid antigen test at screening. Note: * The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant

Exclusion Criteria:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) could be accepted. 2. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 3. Had history or condition of acute myocardial infarction.(2) 4. Had history or condition of glaucoma.(2) 5. Had history or condition of acute circulatory failure (shock, vascular collapse), hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, and aortic/mitral valve stenosis.(6) 6. Had history or condition of hypotension, such as orthostatic hypotension.(4,6) 7. Had history or condition of disease associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage, marked anemia, and hypovolaemia.(6) 8. History of alcohol, drug abuse within 12 months prior to screening for this study. 9. Received any other medications within fourteen days prior to the start of the study. 10. Participated in any clinical study within 3 months after the date of completion. 11. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study. 12. Hypersensitivity to isosorbide dinitrate or similar medication.(2,4,6) 13. Pregnant and breastfeeding women.(4,6) 14. Had symptoms related to COVID-19 (e.g. fever, cough, cold, sore throat, or anosmia) or close contact with COVID-19 patients within fourteen days prior to the start of the study.
 
KET-703/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com