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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-13

Study Completion Date

2020-01-29

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.

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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

Conditions

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Drug Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Furosemide 40 mg tablet

volunteers received Furosemide 40 mg tablet with 240 mL of water

Group Type EXPERIMENTAL

Furosemide 40 mg

Intervention Type DRUG

Administered with 240 mL of water

Lasix® 40 mg Tablet

volunteers received Lasix® 40 mg tablet with 240 mL of water

Group Type ACTIVE_COMPARATOR

Lasix® 40 mg Tablet

Intervention Type DRUG

Administered with 240 mL of water

Interventions

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Furosemide 40 mg

Administered with 240 mL of water

Intervention Type DRUG

Lasix® 40 mg Tablet

Administered with 240 mL of water

Intervention Type DRUG

Other Intervention Names

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Furosemide 40 mg

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes