Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00971295
First received: September 2, 2009
Last updated: December 15, 2014
Last verified: December 2014
Results First Received: December 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuropathic Pain
Interventions: Drug: Metformin
Drug: Eslicarbazepine acetate

  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
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Reporting Groups
  Description
Treatment Sequence A

Treatment Sequence A:

Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period

850 mg metformin hydrochloride, 1200 mg ESL

Treatment Sequence B

Treatment Sequence B:

Metformin period followed by washout period followed by Metformin + Eslicarbazepine acetate

850 mg metformin hydrochloride, 1200 mg ESL


Participant Flow:   Overall Study
    Treatment Sequence A     Treatment Sequence B  
STARTED     10     10  
COMPLETED     10     9  
NOT COMPLETED     0     1  



  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
Metformin + ESL

Metformin HCl 850 mg, ESL 1200 mg

Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days


Baseline Measures
    Metformin + ESL  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Gender  
[units: participants]
 
Female     10  
Male     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax - Maximum Observed Plasma Concentration   [ Time Frame: 3 weeks ]

2.  Secondary:   Tmax - Time of Occurrence of Cmax   [ Time Frame: 3 weeks ]

3.  Secondary:   AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity   [ Time Frame: 3 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


Publications of Results:

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00971295     History of Changes
Other Study ID Numbers: BIA-2093-125
Study First Received: September 2, 2009
Results First Received: December 4, 2014
Last Updated: December 15, 2014
Health Authority: Portugal: National Pharmacy and Medicines Institute