Bioequivalence Study of 40 mg Furosemide Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Lasix® 40 mg Tablets Manufactured by PT. Aventis Pharma, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-1RR1KEK5
Tanggal Input Registry : 20-06-2025

11-12-2024
AUC0-t , AUC0-inf , Cmax
tmax, t1/2
 
Bioequivalence Study of 40 mg Furosemide Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Lasix® 40 mg Tablets Manufactured by PT. Aventis Pharma, Indonesia
Bioequivalence Study of 40 mg Furosemide Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Lasix® 40 mg Tablets Manufactured by PT. Aventis Pharma, Indonesia
Interventional
Furosemide 40 mg Tablets Produced by PT. Novell Pharmaceutical Laboratories
30
 

Inclusion Criteria:

Subjects must satisfied the following criteria to be enrolled in the study: 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 and blood electrolyte (Na, K, Cl).* 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, 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:

Subjects would be excluded if the following reasons existed: 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 of hepatic coma and precoma. 5. Had history or condition of electrolyte deficiencies (hypokalemia and hyponatremia). 6. Had history or condition of hypovolaemia, with or without hypotension, or dehydration. 7. Had history or condition of abnormality in cardiac rhythm or QT prolongation syndrome. 8. Had history or condition of diabetes mellitus. 9. Had history or condition of gout. 10. Had history or condition of hypoproteinemia. 11. Had history or condition of hepatorenal syndrome. 12. Hypersensitivity to furosemide or similar medication. 13. History of alcohol, drug abuse within 12 months prior to screening for this study. 14. Received any other medications within fourteen days prior to the start of the study. 15. Participated in any clinical study within 3 months prior the study. 16. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study.
 
KET-503/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com