At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
FAVICOVIR 200 mg Film Tablet +1 moredrug
Likely dose
FAVICOVIR 200 mg Film Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label,Randomised,Single Oral Dose,Two-period,Cross-over Trial to Assess to Bioequivalence of Favicovir 200 mg FT in Comparison With Avigan 200 mg FT in Healthy Male Subjects Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating FAVICOVIR 200 mg Film Tablet and AVIGAN 200 mg Film Tablets for Bioequivalence. Completed, enrolled 30 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioequivalence
CountriesTurkey (Türkiye)
Timeline
Phase 1CompletedFinished
202120222023202420252026
Enrollment StartMay 2020
Primary CompletionMay 2020
First PostedMay 2020
Study CompletionJun 2020
TodayJul 2026
First PostedMay 28, 2020
Enrollment StartMay 14, 2020
Primary CompletionMay 22, 2020
Study CompletionJun 19, 2020
TodayJul 2, 2026
Enrollment to primary: 8 daysPosted 6.1 years ago
Interventions
FAVICOVIR 200 mg Film Tabletdrug
FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.
AVIGAN 200 mg Film Tabletsdrug
AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.