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| Name | Class |
|---|---|
| Novagenix Bioanalytical Drug R&D Center | 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 |
|---|---|---|---|
| AVICOD then AVIGAN | Experimental | Participants first received AVICOD 200 mg FT manufactured by Pharma Plant in a fasting state. After a washout period of 24 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. |
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| AVIGAN then AVICOD | Experimental | Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 24 hours, they then received AVICOD 200 mg FT manufactured by Pharma Plant in a fasting state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVICOD 200 MG Film Tablet | Drug | AVICOD is containing 200 mg favipiravir manufactured by Pharma Plant,Turkey. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Favipiravir AUC0-tlast | AUC0-tlast of favipiravir will be obtained from plasma concentrations | 0 to 24 hours post dose |
| Favipiravir Cmax | Favipiravir Cmax Cmax of favipiravir will be obtained from plasma concentrations | 0 to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| tmax of Favipiravir | tmax of favipiravir will be obtained from plasma concentrations | 0 to 24 hours post dose |
| t1/2 of Favipiravir | t1/2of favipiravir will be obtained from plasma concentrations |
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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) |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 13, 2020 | |
| Reset | Dec 18, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 13, 2020 | Dec 18, 2020 |
| ID | Term |
|---|---|
| D009040 | Motion Pictures |
| C462182 | favipiravir |
| ID | Term |
|---|---|
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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| AVIGAN 200 MG Film Tablets | Drug | AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan |
|
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| 0 to 24 hours post dose |