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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 |
|---|---|---|---|
| FAVICOVIR then AVIGAN | Experimental | Participants first received Favicovir 200 mg FT manufactured by Atabay 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 FAVICOVIR | Experimental | Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAVICOVIR 200 mg Film Tablet | Drug | FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tlast of Favipiravir | Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours | 0 to 24 hours post-dose |
| Cmax of Favipiravir | Maximum plasma concentration of favipiravir | 0 to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of Favipiravir | Area under the plasma concentration curve to infinite time of favipiravir | 0 to 24 hours post-dose |
| Tmax of Favipiravir | Time to reach maximum plasma concentration of favipiravir |
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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. |
57 subject screened
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: FAVICOVIR Then AVIGAN | Participants first received Favicovir 200 mg FT manufactured by Atabay 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. |
| FG001 | AVIGAN Then FAVICOVIR | Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FAVICOVIR Then AVIGAN | Participants first received Favicovir 200 mg FT manufactured by Atabay 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. |
| BG001 | AVIGAN Then FAVICOVIR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 of Favipiravir | Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours | 29 subjects were analysed and included in statistical analysis. | Posted | 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 | FAVICOVIR 200 MG FT (Atabay-Turkey) | Participants received single oral dose of 200 favipiravir of Atabay-Turkey under fasting conditions. |
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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 | Apr 28, 2020 | Jun 10, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2020 | Jun 10, 2020 | ICF_001.pdf |
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| 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 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan. |
|
|
| 0 to 24 hours post-dose |
| Şahinbey |
| Gaziantep |
| 27000 |
| Turkey (Türkiye) |
| NOT COMPLETED |
|
Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | subjects |
|
|
|
|
| Primary | Cmax of Favipiravir | Maximum plasma concentration of favipiravir | 29 subjects were analysed and included in statistical analysis. | Posted | Mean | Standard Deviation | ng/mL | 0 to 24 hours post-dose |
|
|
|
|
| Secondary | AUC0-inf of Favipiravir | Area under the plasma concentration curve to infinite time of favipiravir | 29 subjects were analysed and included in statistical analysis. | Posted | Mean | Standard Deviation | ng*hr/mL | 0 to 24 hours post-dose |
|
|
|
|
| Secondary | Tmax of Favipiravir | Time to reach maximum plasma concentration of favipiravir | 29 subjects were analysed and included in statistical analysis. | Posted | Mean | Standard Deviation | hr | 0 to 24 hours post-dose |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | AVIGAN 200 MG FT (Toyama-Japan) | Participants received single oral dose of 200 favipiravir of Toyama-Japan under fasting conditions. | 0 | 29 | 0 | 29 | 0 | 29 |
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