Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose 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:
NCT01678976
First received: August 31, 2012
Last updated: December 19, 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
  Hide Participant Flow

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
Period 1 - BIA 2-093; Period 2 - Oxcarbazepine Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
Period 1 - Oxcarbazepine; Period 2 - BIA 2-093 Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093

Participant Flow for 2 periods

Period 1:   First Period
    Period 1 - BIA 2-093; Period 2 - Oxcarbazepine   Period 1 - Oxcarbazepine; Period 2 - BIA 2-093
STARTED   6   7 
COMPLETED   6   6 
NOT COMPLETED   0   1 

Period 2:   Second Period
    Period 1 - BIA 2-093; Period 2 - Oxcarbazepine   Period 1 - Oxcarbazepine; Period 2 - BIA 2-093
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Period 1 - BIA 2-093; Period 2 - Oxcarbazepine Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
Period 1 - Oxcarbazepine; Period 2 - BIA 2-093 Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
Total Total of all reporting groups

Baseline Measures
   Period 1 - BIA 2-093; Period 2 - Oxcarbazepine   Period 1 - Oxcarbazepine; Period 2 - BIA 2-093   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   6   6   12 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   3   3   6 
Male   3   3   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Drug Concentration (Cmax)   [ Time Frame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose ]

2.  Secondary:   Area Under the Plasma Concentration Versus Time Curve (AUC)   [ Time Frame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose ]

3.  Other Pre-specified:   Total of Subjects Reporting at Least One Adverse Event   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: francisco.rocha@bial.com



Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01678976     History of Changes
Other Study ID Numbers: BIA-2093-104
Study First Received: August 31, 2012
Results First Received: November 28, 2014
Last Updated: December 19, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute