NCT04982874

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

Bioequivalence Study of Furosemide in Indonesian Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: PT. Kimia Farma (Persero) Tbk · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Drug Use

Interventions

Type	Name	Description
DRUG	Furosemide 40 mg	Administered with 240 mL of water
DRUG	Lasix® 40 mg Tablet	Administered with 240 mL of water

Timeline

• Start date: 2019-12-13
• Primary completion: 2020-01-17
• Completion: 2020-01-29
• First posted: 2021-07-29
• Last updated: 2023-11-02
• Results posted: 2023-11-02

Locations

1 site across 1 country: Indonesia