BIOEQUIVALENCE STUDY OF FUROSEMIDE 40 MG TABLET PRODUCED BY PT FIRST MEDIPHARMA IN COMPARISON WITH LASIX® (40 MG FUROSEMIDE) TABLET PRODUCED BY PT AVENTIS PHARMA, INDONESIA
Tahapan Penelitian : Complete
Sponsor:
PT. First Medipharma
Mitra Pelaksana:
PT. Omega Medika Farma Laboratori
No Registry
INA-KQ0365L
Tanggal Input Registry : 09-09-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 17-09-2022 |
| Outcome Primer | AUC0→t, AUC0→∞, and Cmax values |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | BIOEQUIVALENCE STUDY OF FUROSEMIDE 40 MG TABLET PRODUCED BY PT FIRST MEDIPHARMA IN COMPARISON WITH LASIX® (40 MG FUROSEMIDE) TABLET PRODUCED BY PT AVENTIS PHARMA, INDONESIA |
| Judul Penelitian Ilmiah | BIOEQUIVALENCE STUDY OF FUROSEMIDE 40 MG TABLET PRODUCED BY PT FIRST MEDIPHARMA IN COMPARISON WITH LASIX® (40 MG FUROSEMIDE) TABLET PRODUCED BY PT AVENTIS PHARMA, INDONESIA |
| Jenis Penelitian | Interventional |
| Intervensi | The participating subjects were ordered to stay overnight in the laboratory staying room before the day of blood sampling and abstain from taking any medication for at least one week before and during period of study. In the next morning (first day of each period) subjects were given orally one of test drug (40 mg Furosemide, produced by PT. First Medipharma) or one of comparator drug (40 mg Lasix, produced by PT. Aventis Pharma, Indonesia) |
| Jumlah Subyek Penelitian | 24 |
| Recruitment Information | |
| Eligibility Criteria | 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 60-80 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 doctor’s 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 blood 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. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-809/UN2.F1/ETIK/PPM.00.02.2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | 112/RPT/OMF/2022 |
| Contact Person | apt. M. Malik, S.Si. |