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| Name | Class |
|---|---|
| Novagenix Bioanalytical Drug R&D Center | NETWORK |
| Farmagen Ar-Ge Biyot. Ltd. Sti | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAVIR then AVIGAN | Experimental | Participants first received Favir 200 mg FT manufactured by Kocak in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./ Japan in a fasting state. |
|
| AVIGAN then FAVIR | Experimental | Participants first received Favir 200 mg FT manufactured by Kocak in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./ Japan in a fasting state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAVIR 200 MG FT | Drug | FAVICOVIR containing 200 mg favipiravir manufactured by Kocak, Turkey. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tlast of favipiravir | AUC0-tlast of favipiravir obtained by plasma concentration | 0 to 24 hours post-dose |
| Cmax of favipiravir | Cmax of favipiravir obtained by plasma concentration | 0 to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of favipiravir | AUC0-inf of favipiravir obtained by plasma concentration | 0 to 24 hours post-dose |
| tmax of favipiravir | tmax of favipiravir obtained by plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muradiye Nacak, MD,PhD | Farmagen Ar-Ge Biyot. Ltd. Sti | Principal Investigator |
| Taner Ezgi, MD | Farmagen Ar-Ge Biyot. Ltd. Sti | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novagenix Drug R&D Center | Akyurt | Ankara | 06970 | Turkey (Türkiye) | ||
| Farmagen Ar-Ge Biyot. Ltd. Sti. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 5, 2020 | Nov 25, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
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| AVIGAN 200 mg FT | Drug | AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan |
|
|
| 0 to 24 hours post-dose |
| Gaziantep |
| Turkey (Türkiye) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |