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: June 18, 2012
Last verified: June 2012

September 2, 2009
June 18, 2012
October 2007
December 2007   (final data collection date for primary outcome measure)
To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the pharmacokinetics of metformin [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00971295 on ClinicalTrials.gov Archive Site
To investigate the tolerability of concomitant administration of ESL and metformin [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuropathic Pain
Drug: 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
Other Names:
  • Glucophage
  • Zebinix
  • Exalief
Experimental: Metformin + ESL
Metformin HCl 850 mg, ESL 1200 mg
Intervention: Drug: Metformin + eslicarbazepine
Rocha JF, Vaz-da-Silva M, Almeida L, Falcão A, Nunes T, Santos AT, Martins F, Fontes-Ribeiro C, Macedo T, Soares-da-Silva P. Effect of eslicarbazepine acetate on the pharmacokinetics of metformin in healthy subjects. Int J Clin Pharmacol Ther. 2009 Apr;47(4):255-61.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged between 18 and 45 years, inclusive.
  • Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
  • Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
  • Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
  • Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
  • Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
  • Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day.
  • Able and willing to give written informed consent.
  • (If female) Not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.
  • (If female) Negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

  • Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
  • Clinically relevant surgical history.
  • History of relevant atopy or drug hypersensitivity.
  • History of alcoholism or drug abuse.
  • Consumed more than 14 units of alcohol a week.
  • Significant infection or known inflammatory process at screening or admission to each treatment period.
  • Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
  • Used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
  • Used any investigational drug or participated in any clinical trial within 6 months prior to screening.
  • Participated in more than 2 clinical trials within the 12 months prior to screening.
  • Donated or received any blood or blood products within the 3 months prior to screening.
  • Vegetarians, vegans or with medical dietary restrictions.
  • Could not communicate reliably with the investigator.
  • Unlikely to co-operate with the requirements of the study.
  • Unwilling or unable to give written informed consent.
  • (If female) Pregnant or breast-feeding.
  • (If female) Of childbearing potential and she did not use an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT00971295
BIA-2093-125
No
Bial - Portela C S.A.
Bial - Portela C S.A.
Not Provided
Principal Investigator: Manuel Vaz-da-Silva, MD, PhD BIAL - Portela & Ca, S.A
Bial - Portela C S.A.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP