Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01679002
First received: August 31, 2012
Last updated: December 31, 2014
Last verified: December 2014
Results First Received: November 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Interventions: Drug: BIA 2-093
Drug: Oxcarbazepine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A

BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.

BIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid

Group B

BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period

BIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od

Group C oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid

Participant Flow:   Overall Study
    Group A     Group B     Group C  
STARTED     4     4     4  
BIA 2-093 900 mg Once-daily Period     4     3     4  
BIA 2-093 450 mg Twice-daily Period     4     4     4  
Oxcarbazepine 450 mg Twice-daily Period     3     4     4  
COMPLETED     3     3     4  
NOT COMPLETED     1     1     0  
Adverse Event                 1                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group A BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
Group B BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 450 mg od
Group C oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 450 mg od - BIA 2-093 450 mg bid
Total Total of all reporting groups

Baseline Measures
    Group A     Group B     Group C     Total  
Number of Participants  
[units: participants]
  4     4     4     12  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     4     4     4     12  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     2     2     2     6  
Male     2     2     2     6  



  Outcome Measures
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1.  Primary:   Cmax - Maximum Observed Plasma Drug Concentration   [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose ]

2.  Secondary:   AUC - Area Under the Plasma Concentration Versus Time Curve   [ Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose ]

3.  Secondary:   Number of of Subjects Reporting at Least One Adverse Event   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
phone: +351 229 866 100
e-mail: jose.rocha@bial.com



Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01679002     History of Changes
Other Study ID Numbers: BIA-2093-110
Study First Received: August 31, 2012
Results First Received: November 28, 2014
Last Updated: December 31, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute