Conditions: Drug Use
Keywords: bioequivalence furosemide Indonesian healthy volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

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

Arms:
arm 1: volunteers received Furosemide 40 mg tablet with 240 mL of water arm 2: volunteers received Lasix® 40 mg tablet with 240 mL of water

Interventions: intervention 1: Furosemide 40 mg intervention 2: Lasix® 40 mg Tablet
Intervention descriptions: intervention 1: Administered with 240 mL of water intervention 2: Administered with 240 mL of water

Protocol document:
Prot_SAP_000.pdf: