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

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-QLM2BQB
Tanggal Input Registry : 13-06-2023

22-06-2022
comparison of Pharmacokinetic parameters (Cmax and AUC) between the test and reference drugs.
 
Bioequivalence Study of 40 mg Furosemide Tablets Manufactured by PT. Bernofarm in Comparison with 40 mg Lasix® Tablets Manufactured by PT. Aventis Pharma, Indonesia.
Bioequivalence Study of 40 mg Furosemide Tablets Manufactured by PT. Bernofarm in Comparison with 40 mg Lasix® Tablets Manufactured by PT. Aventis Pharma, Indonesia.
Interventional
subjects were given a single dose of 40 mg Furosemide of test drug or of reference drug with 240 mL of water. Subjects were administered the drug products in sitting posture. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. The subjects should remain in a comfortable recumbent position for up to 8 hours after dosing and remain under medical surveillance for up to 12 hours after dosing. Before they were allowed to ambulate, they should sit up with legs in a dependent position for one minute prior to standing up. While standing immobile, they should be closely observed for blood pressure changes and/or orthostatic symptoms, including nausea, dizziness, or faintness for at least three minutes.
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Inclusion Criteria:

The inclusion criteria were healthy subjects who/with: - had read the subject information and signed informed consent documents - healthy male and female - age range from 18 – 55 years - body mass index between 18 – 25 kg/m2 - had a normal electrocardiogram - had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg) - had the heart rate within normal range (60 – 100 bpm) - had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. - had passed electrolyte screening related to sodium and potassium - had acceptance to use protection (condom) during intercourse with their spouse during study

Exclusion Criteria:

This study was not eligible for: - those who were pregnant and/or nursing condition - those with a history of contraindication or hypersensitivity to furosemide or other diuretics or other ingredients in the study products, or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction. - those with a history or presence of 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 - those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities - those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day - those who had participated in any clinical study within 3 months prior to the study (< 90 days). - those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study. - those who were smoker - those with a history of travelling to another city within the last 14 days - those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood - those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days - those who were positive to SARS CoV-2 antigen test - those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential). - those with a history of drug or alcohol abuse within 12 months prior to screening for this study. - those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-345/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
Nabila Mudin S