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

Not Applicable

Completed

Brief Summary: The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.

Detailed Description: Twenty four healty volunteers were given a single dose of Furosemide 40 mg Tablet or Lasix® 40 mg Tablet with 240 mL of water beneath fasting condition. Then the blood samples for Furosemide were drawn and analyzed using UPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lasix® 40 mg Tablet	Lasix® 40 mg Tablet	volunteers received Lasix® 40 mg tablet with 240 mL of water
Furosemide 40 mg tablet	Furosemide 40 mg	volunteers received Furosemide 40 mg tablet with 240 mL of water

Primary Outcome Measures

Name	Time	Method
Geometric Mean Ratio of Maximum Concentration	before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after drug administration	The ratio between test drug and reference drug
Geometric Mean Ratio of Area Under Curve	before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after drug administration	The ratio between test drug and reference drug

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics Parameter	before dosing (0 h) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after drug administration	Area Under Curve from 0 to 24 hours