Bioequivalence Study of Furosemide in Indonesian Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Geometric Mean Ratio of Maximum Concentration
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Furosemide 40 mg tablet
volunteers received Furosemide 40 mg tablet with 240 mL of water
Intervention: Furosemide 40 mg (Drug)
Lasix® 40 mg Tablet
volunteers received Lasix® 40 mg tablet with 240 mL of water
Intervention: Lasix® 40 mg Tablet (Drug)
Outcomes
Primary Outcomes
Geometric Mean Ratio of Maximum Concentration
Time Frame: 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
Time Frame: 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 Outcomes
- 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)