Trial Outcomes & Findings for Terbinafine HCl 250 mg Tablet Under Fasting Conditions (NCT NCT00833586)

NCT ID: NCT00833586

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: Blood samples collected over 144 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Terbinafine (Test) First Terbinafine HCl 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	14	14
First Intervention COMPLETED	14	14
First Intervention NOT COMPLETED	0	0
Washout: 14 Days STARTED	14	14
Washout: 14 Days COMPLETED	14	14
Washout: 14 Days NOT COMPLETED	0	0
Second Intervention STARTED	14	14
Second Intervention COMPLETED	14	14
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Terbinafine HCl 250 mg Tablet Under Fasting Conditions

Baseline characteristics by cohort

Measure	Terbinafine (Test) First n=14 Participants Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period	Lamisil® (Reference) First n=14 Participants Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Biracial	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 144 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Terbinafine n=28 Participants Terbinafine HCl 250 mg Tablet (test) dosed in either period	Lamisil® n=28 Participants Lamisil® 250 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Terbinafine in Plasma	840.2 ng/mL Standard Deviation 310.8	873.2 ng/mL Standard Deviation 299.3

PRIMARY outcome

Timeframe: Blood samples collected over 144 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Terbinafine n=28 Participants Terbinafine HCl 250 mg Tablet (test) dosed in either period	Lamisil® n=28 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	4425 ng*h/mL Standard Deviation 1733	4062 ng*h/mL Standard Deviation 2020

PRIMARY outcome

Timeframe: Blood samples collected over 144 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Terbinafine n=28 Participants Terbinafine HCl 250 mg Tablet (test) dosed in either period	Lamisil® n=28 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	3795 ng*h/mL Standard Deviation 1498	3765 ng*h/mL Standard Deviation 1636

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

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