NCT04400682

Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions

Open-label, Randomised, Single Oral Dose, Two-period, Cross-over Trial to Assess to Bioequivalence of Favira 200 mg FT in Comparison With Avigan 200 mg FT in Healthy Male Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novelfarma Ilaç San. ve Tic. Ltd. Sti. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting conditions with current pandemic precautions.

Detailed description

Favipiravir is a drug with a mechanism of action different from that of the existing influenza antiviral drugs and effective against all types and sub-types of human influenza A, B and C viruses in vitro, showing anti-viral activity against various influenza virus strains including avian and swine viruses. Favipiravir also has shown anti-viral activity even against amantadine, oseltamivir and zanamivir-resistant influenza viruses in vitro. The mechanism of action of favipiravir is the selective inhibition of RNA polymerase by favipiravir ribosyl triphosphate formed by cellular enzymes in the influenza virus leading to antiviral activity.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	FAVIRA 200 MG Film Tablet	FAVIRA is containing 200 mg favipiravir manufactured by Novelfarma, Turkey.
DRUG	AVIGAN 200 MG Film Tablets	AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan

Timeline

• Start date: 2020-05-28
• Primary completion: 2020-06-05
• Completion: 2020-06-18
• First posted: 2020-05-22
• Last updated: 2020-08-11
• Results posted: 2020-08-11

Locations

2 sites across 1 country: Turkey (Türkiye)