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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 |
|---|---|---|---|
| Test Drug | Experimental | Loqular 200 mg Film Tablet containing 200 mg favipiravir (World Medicine İlaç-Turkey) |
|
| Reference drug | Active Comparator | Avigan 200 mg Film Tablet containing 200 mg favipiravir (Toyama Chemical Industry Co.Ltd./Japan) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test: Favipiravir 200 mg (LOQULAR) | Drug | Test Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary PK End Points AUC0-tlast | AUC0-tlast of favipiravir | 12 weeks |
| Primary PK End Points Cmax | Cmax of favipiravir | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary PK End Points AUC0-inf | AUC0-inf of favipiravir | 14 weeks |
| Secondary PK End Points tmax | tmax of favipiravir | 15 weeks |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novagenix Drug R&D Center | Akyurt | Ankara | 06970 | Turkey (Türkiye) | ||
| Farmagen Ar-Ge Biyot. Ltd. Sti. |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 13, 2020 | |
| Reset | Dec 18, 2020 |
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| Reference: Favipiravir 200 mg (Avigan) | Drug | Reference Drug |
|
|
| Şahinbey |
| Gaziantep |
| 27000 |
| Turkey (Türkiye) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 13, 2020 | Dec 18, 2020 |
| ID | Term |
|---|---|
| C462182 | favipiravir |
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