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

NCT04982874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-02

Study results available
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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.

Conditions

  • Drug Use

Interventions

DRUG

Furosemide 40 mg

Administered with 240 mL of water

DRUG

Lasix® 40 mg Tablet

Administered with 240 mL of water

Sponsors & Collaborators

  • PT Pharma Metric Labs

    collaborator INDUSTRY

  • PT. Kimia Farma (Persero) Tbk

    lead INDUSTRY

Principal Investigators

  • Frans D Suyatna · PT Pharma Metric Labs

  • I Gusti Putu Bagus Diana Virgo · PT Pharma Metric Labs

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2020-01-17
Completion
2020-01-29

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982874 on ClinicalTrials.gov