Trial Outcomes & Findings for Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate (NCT NCT02284880)
NCT ID: NCT02284880
Last Updated: 2015-01-12
Results Overview
Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period
Results posted on
2015-01-12
Participant Flow
Participant milestones
| Measure |
400 mg BIA 2-093 Group 1
In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
|
400 mg BIA 2-093 Group 2
In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
|
800 mg BIA 2-093 Group 1
In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
|
800 mg BIA 2-093 Group 2
In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
10
|
10
|
|
Overall Study
First Period (4 Days)
|
11
|
9
|
10
|
10
|
|
Overall Study
Wash-out Period (7 Days)
|
11
|
9
|
10
|
10
|
|
Overall Study
Second Period (4 Days)
|
11
|
9
|
8
|
10
|
|
Overall Study
COMPLETED
|
11
|
9
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate
Baseline characteristics by cohort
| Measure |
400 mg BIA 2-093
n=20 Participants
In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
|
800 mg BIA 2-093
n=20 Participants
In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
|
Total
n=40 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
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing periodReference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite
Outcome measures
| Measure |
400 mg BIA 2-093
n=20 Participants
In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
|
800 mg BIA 2-093
n=18 Participants
In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
|
|---|---|---|
|
Cmax - Maximum Plasma Concentration
Cmax (BIA 2-005 Reference)
|
6461 ng/ml
Standard Deviation 1346
|
13183 ng/ml
Standard Deviation 2564
|
|
Cmax - Maximum Plasma Concentration
Cmax (BIA 2-005 Test)
|
6547 ng/ml
Standard Deviation 1524
|
12988 ng/ml
Standard Deviation 2215
|
PRIMARY outcome
Timeframe: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing periodReference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite
Outcome measures
| Measure |
400 mg BIA 2-093
n=20 Participants
In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
|
800 mg BIA 2-093
n=18 Participants
In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
|
|---|---|---|
|
Tmax - Time of Occurrence of Cmax
Tmax (BIA 2-005 Reference)
|
2.00 hours
Interval 0.5 to 6.0
|
2.00 hours
Interval 1.0 to 4.02
|
|
Tmax - Time of Occurrence of Cmax
Tmax (BIA 2-005 Test)
|
2.00 hours
Interval 0.5 to 6.0
|
1.75 hours
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing periodReference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite
Outcome measures
| Measure |
400 mg BIA 2-093
n=20 Participants
In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
|
800 mg BIA 2-093
n=18 Participants
In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
|
|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
AUC0-t (BIA 2-005 Reference)
|
112568 ng.hr/ml
Standard Deviation 23011
|
279035 ng.hr/ml
Standard Deviation 60183
|
|
AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
AUC0-t (BIA 2-005 Test)
|
108224 ng.hr/ml
Standard Deviation 23971
|
278734 ng.hr/ml
Standard Deviation 61738
|
Adverse Events
Before Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
400 mg Tablet of ESL (MF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
400 mg Tablet of ESL (TBM)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
800 mg Tablet of ESL (MF)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
800 mg Tablet of ESL (TBM)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
After Follow-up Visit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Before Treatment
n=40 participants at risk
Before treatment with ESL ESL - Eslicarbazepine acetate, BIA 2-093
|
400 mg Tablet of ESL (MF)
n=20 participants at risk
400 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
|
400 mg Tablet of ESL (TBM)
n=20 participants at risk
400 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
|
800 mg Tablet of ESL (MF)
n=20 participants at risk
800 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
|
800 mg Tablet of ESL (TBM)
n=18 participants at risk
800 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
|
After Follow-up Visit
n=40 participants at risk
After Follow-up visit ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation TBM - To be marketed
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.6%
1/18
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/18
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Asthenia
|
0.00%
0/40
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.6%
1/18
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/40
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/18
|
0.00%
0/40
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/40
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
5.6%
1/18
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.6%
1/18
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
2.5%
1/40
|
0.00%
0/20
|
5.0%
1/20
|
15.0%
3/20
|
5.6%
1/18
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/40
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.6%
1/18
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/18
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/18
|
0.00%
0/40
|
Additional Information
Head of Clinical Research
Bial - Portela & Cª, S.A.
Phone: +351 229 866 100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER