Bioequivalence Study of 300 mg Irbesartan Film Coated Tablets Produced by PT. Etercon Pharma in comparison with Aprovel® Film Coated Tablets Manufactured by Sanofi Winthrop Industrie, France, Under License from Sanofi Clir SNC, France, Imported by PT. Aventis Pharma, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-4LBBWD59
Tanggal Input Registry : 30-12-2021

04-10-2021
Cmax, AUC0-t, AUC0-∞
tmax, t1/2
 
Bioequivalence Study of 300 mg Irbesartan Film Coated Tablets Produced by PT. Etercon Pharma in comparison with Aprovel® Film Coated Tablets Manufactured by Sanofi Winthrop Industrie, France, Under License from Sanofi Clir SNC, France, Imported by PT. Aventis Pharma, Indonesia
Bioequivalence Study of 300 mg Irbesartan Film Coated Tablets Produced by PT. Etercon Pharma in comparison with Aprovel® Film Coated Tablets Manufactured by Sanofi Winthrop Industrie, France, Under License from Sanofi Clir SNC, France, Imported by PT. Aventis Pharma, Indonesia
Interventional
300 mg Irbesartan Film Coated Tablets Produced by PT. Etercon Pharma
34
 

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 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 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 at screening, before period I and before period II of the study. 13. Negative result for rapid antigen test of COVID-19 (Coronavirus) during COVID- 19 pandemic at screening, before period I and before period II of the study. 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) can be accepted. 2. Pregnant woman or nursing mother. (3) 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Potentially hypersensitive to irbesartan. (3) 5. History of alcohol, drug abuse within 12 months prior to screening for this study. 6. Received any other medications within fourteen days prior to the start of the study. 7. Participated in any clinical study within 3 months after the date of completion. 8. Donation or loss more than 300 ml of blood within 3 months prior to the screening of the study. 9. Positive result for rapid antigen test of COVID-19 (Coronavirus) at screening, before starting period I or II.
 
KET-1056/UN2.F1/ETIK/PPM.00.02/2020
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com