Trials / Completed
CompletedNCT04407000
Bioequivalence Study of Favipiravir 200 mg Film Tablet (World Medicine, Turkey) Under Fasting Conditions
Open-label,Randomised,Single Oral Dose,Two-period,Cross-over Trial to Assess to Bioequivalence of Loqular 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
- World Medicine ILAC SAN. ve TIC. A.S. · 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Test: Favipiravir 200 mg (LOQULAR) | Test Drug |
| DRUG | Reference: Favipiravir 200 mg (Avigan) | Reference Drug |
Timeline
- Start date
- 2020-06-23
- Primary completion
- 2020-07-20
- Completion
- 2020-08-08
- First posted
- 2020-05-29
- Last updated
- 2020-08-11
Locations
2 sites across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04407000. Inclusion in this directory is not an endorsement.