Trial Outcomes & Findings for Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation (NCT NCT02283840)

NCT ID: NCT02283840

Last Updated: 2014-12-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration

Results posted on

2014-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A:BIA 2-093 400 mg One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Cohort B:BIA 2-093 600 mg One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Cohort C:BIA 2-093 800 mg One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	19	20
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A:BIA 2-093 400 mg n=20 Participants One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Cohort B:BIA 2-093 600 mg n=20 Participants One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Cohort C:BIA 2-093 800 mg n=20 Participants One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Total n=60 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants

PRIMARY outcome

Timeframe: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration

Outcome measures

Outcome measures
Measure	Cohort A:BIA 2-093 400 mg n=20 Participants One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Cohort B:BIA 2-093 600 mg n=19 Participants One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Cohort C:BIA 2-093 800 mg n=20 Participants One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093
Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005 Cmax (BIA 2-005) Test	7107.7 ng/mL Standard Deviation 2004.4	10724.8 ng/mL Standard Deviation 1941.2	13186.4 ng/mL Standard Deviation 2307.6
Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005 Cmax (BIA 2-005) Reference	6660.3 ng/mL Standard Deviation 1545.2	10404.5 ng/mL Standard Deviation 1716.7	12767.6 ng/mL Standard Deviation 2528.0

PRIMARY outcome

Timeframe: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration

Outcome measures

Outcome measures
Measure	Cohort A:BIA 2-093 400 mg n=20 Participants One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Cohort B:BIA 2-093 600 mg n=19 Participants One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093	Cohort C:BIA 2-093 800 mg n=20 Participants One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM) One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF) BIA 2-093
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time AUC0-t (BIA 2-093) Test	125739.8 ng.h/mL Standard Deviation 29045.7	219560.8 ng.h/mL Standard Deviation 39740.5	294749.1 ng.h/mL Standard Deviation 48044.1
AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time AUC0-t (BIA 2-093) Reference	122134.1 ng.h/mL Standard Deviation 27602.3	215750.4 ng.h/mL Standard Deviation 44444.6	293959.9 ng.h/mL Standard Deviation 49385.3

PRIMARY outcome

Timeframe: prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration