Bioequivalence Study of 50 mg Losartan Potassium Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Cozaar® 50 mg Film Coated Tablets Manufactured by Organon Pharma (UK) Limited, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
INA-49ACHCYY
Tanggal Input Registry : 24-04-2025

02-09-2024
AUC0-t , AUC0-inf , Cmax
tmax, t1/2
 
Bioequivalence Study of 50 mg Losartan Potassium Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Cozaar® 50 mg Film Coated Tablets Manufactured by Organon Pharma (UK) Limited, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Indonesia
Bioequivalence Study of 50 mg Losartan Potassium Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Cozaar® 50 mg Film Coated Tablets Manufactured by Organon Pharma (UK) Limited, England, Registered and Packed by PT. Organon Pharma Indonesia Tbk, Indonesia
Interventional
Losartan Potassium 50 mg Tablet Salut Selaput manufactured by PT. Novell Pharmaceutical Laboratories
27
 

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. 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 (were done for female subjects at screening and before every period of the study). 13. Practiced sexual abstinence or was using non-hormonal contraception during 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) could be accepted. 2. Pregnant women or nursing mother 3. Had history of hepatic, cardiovascular, gastrointestinal or renal disease. 4. Had history or condition of electrolyte or fluid imbalance.(1,2) 5. Had history or condition of hypotension, coronary heart disease, cerebrovascular disease, heart failure, aortic or mitral valve stenosis, or obstructive hyperthropic cardiomyopathy.(2,3) 6. Hypersensitivity to losartan or similar medication.(1,2,3) 7. History of alcohol, drug abuse within 12 months prior to screening for this study. 8. Received any other medications within fourteen days prior to the start of the study. 9. Participated in any clinical study within 3 months prior the study. 10. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-1549/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com