Bioequivalence study of Diutensi tablet (40 mg Furosemide) produced by PT. Konimex in comparison with Lasix® (40 mg Furosemide) tablet manufactured by PT. Sanofi Aventis Indonesia

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-EPQFKH4
Tanggal Input Registry : 25-05-2022

06-04-2022
AUC0-t dan Cmax
AUC0-∞, t1/2, dan tmax
 
Bioequivalence study of Diutensi tablet (40 mg Furosemide) produced by PT. Konimex in comparison with Lasix® (40 mg Furosemide) tablet manufactured by PT. Sanofi Aventis Indonesia
Bioequivalence study of Diutensi tablet (40 mg Furosemide) produced by PT. Konimex in comparison with Lasix® (40 mg Furosemide) tablet manufactured by PT. Sanofi Aventis Indonesia
Eksperimental
The reference drug was the market available Lasix® (40 mg Furosemide) tablet manufactured by PT. Sanofi Aventis Indonesia, batch number 1DN016, expiration date on April 2024. The test drug was Diutensi tablet (40 mg Furosemide) produced by PT. Konimex, batch number F1P4L9(SEP21A02); manufacturing date on September 2021; expiration date on September 2023.
18
 

Inclusion Criteria:

- Willing to sign the informed consent, - Age 18 – 55 years, - Body mass index between 18 – 25 kg/m2, - Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 6080 mmHg), heart rate 60 – 90 beats per minute, - Healthy male (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, fasting blood sugar and urinalysis; history of disease, and physical examination), - Show normal result or within the acceptance range (not clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result - Normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of blood electrolyte concentration (Na & K).

Exclusion Criteria:

- Contraindicated and/or has history of hypersensitivity to Furosemide, Sulfonamide, Sulfonylurea or related drug - With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, - Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day, - Participated in any clinical study within 3 months prior the study, - Donated or lost 300 mL (or more) of blood within 3 months prior the study, - Smoke more than 10 sticks of cigarettes a day, - Have any bleeding or coagulation disorder, - Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV, - With the history of alcohol and drug abuse - If the study is conducted in Covid-19 pandemic situation, the exclusions criteria bellow must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days, b. With history or present sore throat, fever (temperature more than 37oC) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test
 
KET-174/UN2.F1/ETIK/PPM.00.02/2022
NA
RG.01.02.321.03.22.00730/UB
143/FORM/OMF/2021
apt. Haranissa Dea Oktania