Trial Outcomes & Findings for Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions (NCT NCT04406194)
NCT ID: NCT04406194
Last Updated: 2020-08-14
Results Overview
Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0 to 24 hours post-dose
Results posted on
2020-08-14
Participant Flow
57 subject screened
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
STARTED
|
15
|
15
|
|
Period 1
COMPLETED
|
15
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
15
|
14
|
|
Period 2
COMPLETED
|
15
|
14
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
FAVICOVIR Then AVIGAN
n=15 Participants
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
n=15 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
29 years
n=7 Participants
|
29 years
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 subjects
n=5 Participants
|
15 subjects
n=7 Participants
|
30 subjects
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hours post-dosePopulation: 29 subjects were analysed and included in statistical analysis.
Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours
Outcome measures
| Measure |
Favicovir 200 mg FT
n=29 Participants
Participants received single oral dose of 200 mg favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.
|
Avigan 200 mg FT
n=29 Participants
Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.
|
|---|---|---|
|
AUC0-tlast of Favipiravir
|
9641.989 ng*hr/mL
Standard Deviation 2545.1
|
9907.170 ng*hr/mL
Standard Deviation 2423.5
|
PRIMARY outcome
Timeframe: 0 to 24 hours post-dosePopulation: 29 subjects were analysed and included in statistical analysis.
Maximum plasma concentration of favipiravir
Outcome measures
| Measure |
Favicovir 200 mg FT
n=29 Participants
Participants received single oral dose of 200 mg favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.
|
Avigan 200 mg FT
n=29 Participants
Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.
|
|---|---|---|
|
Cmax of Favipiravir
|
5411.624 ng/mL
Standard Deviation 2025.6
|
5002.171 ng/mL
Standard Deviation 1231.1
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dosePopulation: 29 subjects were analysed and included in statistical analysis.
Area under the plasma concentration curve to infinite time of favipiravir
Outcome measures
| Measure |
Favicovir 200 mg FT
n=29 Participants
Participants received single oral dose of 200 mg favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.
|
Avigan 200 mg FT
n=29 Participants
Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.
|
|---|---|---|
|
AUC0-inf of Favipiravir
|
9910.494 ng*hr/mL
Standard Deviation 2618.9
|
10152.115 ng*hr/mL
Standard Deviation 2507.694
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dosePopulation: 29 subjects were analysed and included in statistical analysis.
Time to reach maximum plasma concentration of favipiravir
Outcome measures
| Measure |
Favicovir 200 mg FT
n=29 Participants
Participants received single oral dose of 200 mg favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.
|
Avigan 200 mg FT
n=29 Participants
Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.
|
|---|---|---|
|
Tmax of Favipiravir
|
0.609 hr
Standard Deviation 0.343
|
0.733 hr
Standard Deviation 0.478
|
Adverse Events
FAVICOVIR 200 MG FT (Atabay-Turkey)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AVIGAN 200 MG FT (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