Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers

Inclusion Criteria

• have read the subject information and signed informed consent documents
• age 18 - 55 years
• body mass index between 18-25 kg/m2
• have a normal electrocardiogram
• blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
• heart rate within normal range (60-100 bpm)
• with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
• acceptance to use protection (condom) during intercourse with their spouse throughout the study

Exclusion Criteria

• those who are pregnant and/or nursing women
• those with a history of hypersensitivity to furosemide, or other diuretics or other ingredients in the drugs 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 pharmacokinetic 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 are 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 have participated in any clinical study within 3 months prior to the study (< 90 days)
• those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study
• those who smoke more than 10 cigarettes a day
• those who are 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 are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access