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| ID | Type | Description | Link |
|---|---|---|---|
| FARGE 367 | Other Identifier | FARMAGEN |
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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 |
|---|---|---|---|
| FAVIRA then AVIGAN | Experimental | Participants first received Favira 200 mg FT manufactured by Novelfarma 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 FAVIRA | Experimental | Participants first received Avigan FT 200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favira 200 mg FT manufactured by Novelfarma in a fasting state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAVIRA 200 MG Film Tablet | Drug | FAVIRA is containing 200 mg favipiravir manufactured by Novelfarma, Turkey. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|---|---|---|
| AUC0-inf of Favipiravir | AUC0-inf of favipiravir will be obtained from plasma concentrations | 0 to 24 hours post dose |
| Tmax of Favipiravir | tmax of 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) | ||
| Farmagen Ar-Ge Biyot. Ltd. Sti. |
46 subjects screened
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| ID | Title | Description |
|---|---|---|
| FG000 | FAVIRA Then AVIGAN | Participants first received Favira 200 mg FT manufactured by Novelfarma 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. FAVIRA 200 MG FT: FAVIRA containing 200 mg favipiravir manufactured by Novelfarma, Turkey. AVIGAN 200 mg FT: AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan |
| FG001 | AVIGAN Then FAVIRA | Participants first received Avigan FT 200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favira 200 mg FT manufactured by Novelfarma in a fasting state. FAVIRA 200 MG FT: FAVIRA containing 200 mg favipiravir manufactured by Novelfarma, Turkey. AVIGAN 200 mg FT: AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FAVIRA Then AVIGAN | Participants first received Favira 200 mg FT manufactured by Novelfarma 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. FAVIRA 200 MG FT: FAVIRA containing 200 mg favipiravir manufactured by Novelfarma, Turkey. AVIGAN 200 mg FT: AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-tlast | AUC0-tlast of favipiravir will be obtained from plasma concentrations | Posted | Least Squares Mean | Standard Deviation | ng*hr/mL | 0 to 24 hours post dose |
|
9 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FAVIRA (Novelfarma-Turkey) | Participants received an oral dose of 200 mg favipiravir (Novelfarma-Turkey) in fasting state. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aydin Erenmemisoglu | Farmagen | +90 532 551 0082 | a.erenmemisoglu@farmagenarge.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2020 | Jun 20, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 11, 2020 | Jun 21, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
| D009040 | Motion Pictures |
| 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 |
|
|
| 0 to 24 hours post dose |
| Şahinbey |
| Gaziantep |
| 27000 |
| Turkey (Türkiye) |
| NOT COMPLETED |
|
| BG001 | AVIGAN Then FAVIRA | Participants first received Avigan FT 200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favira 200 mg FT manufactured by Novelfarma in a fasting state. FAVIRA 200 MG FT: FAVIRA containing 200 mg favipiravir manufactured by Novelfarma, Turkey. AVIGAN 200 mg FT: AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Favipiravir Cmax | Favipiravir Cmax Cmax of favipiravir will be obtained from plasma concentrations | All of the 25 subjects were included in statistical analysis. | Posted | Least Squares Mean | Standard Deviation | ng/mL | 0 to 24 hours post dose |
|
|
|
|
| Secondary | AUC0-inf of Favipiravir | AUC0-inf of favipiravir will be obtained from plasma concentrations | All of the 25 subjects were included in statistical analysis | Posted | Least Squares Mean | Standard Deviation | ng*hr/mL | 0 to 24 hours post dose |
|
|
|
|
| Secondary | Tmax of Favipiravir | tmax of favipiravir will be obtained from plasma concentrations | All of the 25 subjects were included in statistical analysis. | Posted | Mean | Standard Deviation | hr | 0 to 24 hours post dose |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | AVIGAN (Toyama-Japan | Participants received an oral dose of 200 mg favipiravir (Toyama-Japan) in fasting state. | 0 | 25 | 0 | 25 | 0 | 25 |
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