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

Kimia Farma

Status

Completed

Conditions

Drug Use

Treatments

Drug: Lasix® 40 mg Tablet

Drug: Furosemide 40 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04982874

447/STD/PML/2019

Details and patient eligibility

About

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.

Full 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

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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