Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04407000
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2020-05-24
Brief Title:
Bioequivalence Study of Favipiravir 200 mg Film Tablet World Medicine Turkey Under Fasting Conditions
Sponsor:
World Medicine ILAC SAN ve TIC AS
Organization:
World Medicine ILAC SAN ve TIC AS
Study Overview
Official Title:
Open-labelRandomisedSingle Oral DoseTwo-periodCross-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
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Favipiravir
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None