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

Study Overview
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Brief Summary
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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
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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

Official Title
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Bioequivalence Study of Furosemide in Indonesian Healthy Volunteers

Conditions
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Drug Use

Intervention / Treatment
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* Drug: Furosemide 40 mg
* Drug: Lasix® 40 mg Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized, single blind, single dose, 2-period, cross-over design with one week washout period between each treatment in 24 healthy volunteers beneath fasting condition
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide 40 mg tablet<br>volunteers received Furosemide 40 mg tablet with 240 mL of water | Drug: Furosemide 40 mg<br>* Administered with 240 mL of water<br>|
| Active Comparator: Lasix® 40 mg Tablet<br>volunteers received Lasix® 40 mg tablet with 240 mL of water | Drug: Lasix® 40 mg Tablet<br>* Administered with 240 mL of water<br>* Other names: Furosemide 40 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Ratio of Maximum Concentration | The ratio between test drug and reference drug | 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 | 
| Geometric Mean Ratio of Area Under Curve | The ratio between test drug and reference drug | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics Parameter | Maximum plasma 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 | 
| Pharmacokinetics Parameter | Area Under Curve from 0 to 24 hours | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence, furosemide, Indonesian healthy volunteers