Trial Outcomes & Findings for Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions (NCT NCT04400682)
NCT ID: NCT04400682
Last Updated: 2020-08-11
Results Overview
AUC0-tlast of favipiravir will be obtained from plasma concentrations
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0 to 24 hours post dose
Results posted on
2020-08-11
Participant Flow
46 subjects screened
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Period 1
STARTED
|
15
|
15
|
|
Period 1
COMPLETED
|
14
|
11
|
|
Period 1
NOT COMPLETED
|
1
|
4
|
|
Period 2
STARTED
|
14
|
11
|
|
Period 2
COMPLETED
|
14
|
11
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
4
|
Baseline Characteristics
Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
FAVIRA Then AVIGAN
n=15 Participants
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
|
AVIGAN Then FAVIRA
n=15 Participants
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
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 2.9 • n=99 Participants
|
33 years
STANDARD_DEVIATION 3.4 • n=107 Participants
|
32 years
STANDARD_DEVIATION 3.15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hours post doseAUC0-tlast of favipiravir will be obtained from plasma concentrations
Outcome measures
| Measure |
FAVIRA (Novelfarma-Turkey)
n=25 Participants
Participants received an oral single dose of 200 mg favipiravir (Novelfarma-Turkey) in fasting state.
|
AVIGAN (Toyama-Japan)
n=25 Participants
Participants received an oral single dose of 200 mg favipiravir (Toyama-Japan) in fasting state.
|
|---|---|---|
|
AUC0-tlast
|
10400.038 ng*hr/mL
Standard Deviation 2803.269
|
9907.948 ng*hr/mL
Standard Deviation 2487.955
|
PRIMARY outcome
Timeframe: 0 to 24 hours post dosePopulation: All of the 25 subjects were included in statistical analysis.
Favipiravir Cmax Cmax of favipiravir will be obtained from plasma concentrations
Outcome measures
| Measure |
FAVIRA (Novelfarma-Turkey)
n=25 Participants
Participants received an oral single dose of 200 mg favipiravir (Novelfarma-Turkey) in fasting state.
|
AVIGAN (Toyama-Japan)
n=25 Participants
Participants received an oral single dose of 200 mg favipiravir (Toyama-Japan) in fasting state.
|
|---|---|---|
|
Favipiravir Cmax
|
5242.459 ng/mL
Standard Deviation 1761.452
|
4969.881 ng/mL
Standard Deviation 1325.164
|
SECONDARY outcome
Timeframe: 0 to 24 hours post dosePopulation: All of the 25 subjects were included in statistical analysis
AUC0-inf of favipiravir will be obtained from plasma concentrations
Outcome measures
| Measure |
FAVIRA (Novelfarma-Turkey)
n=25 Participants
Participants received an oral single dose of 200 mg favipiravir (Novelfarma-Turkey) in fasting state.
|
AVIGAN (Toyama-Japan)
n=25 Participants
Participants received an oral single dose of 200 mg favipiravir (Toyama-Japan) in fasting state.
|
|---|---|---|
|
AUC0-inf of Favipiravir
|
10400.038 ng*hr/mL
Standard Deviation 2803.269
|
10186.389 ng*hr/mL
Standard Deviation 2528.923
|
SECONDARY outcome
Timeframe: 0 to 24 hours post dosePopulation: All of the 25 subjects were included in statistical analysis.
tmax of favipiravir will be obtained from plasma concentrations
Outcome measures
| Measure |
FAVIRA (Novelfarma-Turkey)
n=25 Participants
Participants received an oral single dose of 200 mg favipiravir (Novelfarma-Turkey) in fasting state.
|
AVIGAN (Toyama-Japan)
n=25 Participants
Participants received an oral single dose of 200 mg favipiravir (Toyama-Japan) in fasting state.
|
|---|---|---|
|
Tmax of Favipiravir
|
0.766 hr
Standard Deviation 0.394
|
0.770 hr
Standard Deviation 0.444
|
Adverse Events
FAVIRA (Novelfarma-Turkey)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AVIGAN (Toyama-Japan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER