Trial Outcomes & Findings for Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions (NCT NCT00833664)
NCT ID: NCT00833664
Last Updated: 2023-05-30
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Blood samples collected over144 hour period
Results posted on
2023-05-30
Participant Flow
Participant milestones
| Measure |
Terbinafine (Test) First
Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
|
Lamisil® (Reference) First
Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
11
|
|
First Intervention
COMPLETED
|
11
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout: 14 Days
STARTED
|
11
|
11
|
|
Washout: 14 Days
COMPLETED
|
10
|
11
|
|
Washout: 14 Days
NOT COMPLETED
|
1
|
0
|
|
Second Intervention
STARTED
|
10
|
11
|
|
Second Intervention
COMPLETED
|
10
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Terbinafine (Test) First
n=11 Participants
Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
|
Lamisil® (Reference) First
n=11 Participants
Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Biracial
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over144 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Terbinafine
n=21 Participants
Terbinafine 250 mg Tablet (test) dosed in either period
|
Lamisil®
n=21 Participants
Lamisil® 250 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration - Terbinafine in Plasma
|
906 ng/mL
Standard Deviation 196
|
971 ng/mL
Standard Deviation 417
|
PRIMARY outcome
Timeframe: Blood samples collected over 144 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Terbinafine
n=21 Participants
Terbinafine 250 mg Tablet (test) dosed in either period
|
Lamisil®
n=21 Participants
Lamisil® 250 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma
|
4870 ng*h/mL
Standard Deviation 1618
|
5953 ng*h/mL
Standard Deviation 4170
|
PRIMARY outcome
Timeframe: Blood samples collected over 144 hour periodPopulation: Data from all subjects who completed the study were included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Terbinafine
n=21 Participants
Terbinafine 250 mg Tablet (test) dosed in either period
|
Lamisil®
n=21 Participants
Lamisil® 250 mg Tablet (reference) dosed in either period
|
|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma
|
4652 ng*h/mL
Standard Deviation 1925
|
4835 ng*h/mL
Standard Deviation 2795
|
Adverse Events
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 Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER