At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
FAVIRA 200 MG Film Tablet +1 moredrug
Likely dose
FAVIRA 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 Favira 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 FAVIRA 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
First PostedMay 2020
Enrollment StartMay 2020
Primary CompletionJun 2020
Study CompletionJun 2020
TodayJul 2026
First PostedMay 22, 2020
Enrollment StartMay 28, 2020
Primary CompletionJun 5, 2020
Study CompletionJun 18, 2020
TodayJul 2, 2026
Enrollment to primary: 7 daysPosted 6.1 years ago
Interventions
FAVIRA 200 MG Film Tabletdrug
FAVIRA is containing 200 mg favipiravir manufactured by Novelfarma, Turkey.
AVIGAN 200 MG Film Tabletsdrug
AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan