Status:
COMPLETED
Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.
Detailed Description
This was a single centre, two-way crossover, randomised, open-label study in 24 healthy volunteers. The volunteers will receive an oral single-dose of simvastatin 80 mg on two occasions - once adminis...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18 to 45 years, inclusive
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive
- Healthy as determined by pre-study medical history, physical examination, vital signs, 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 ex-smokers
- Able and willing to give written informed consent;
- If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she uses one of the following methods of contraception: double barrier method: 1 male barrier method \[male condom\] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);
- If female, has a negative urine pregnancy test at screening and admission to each treatment period.
Exclusion
- 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 any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives, simvastatin or other statins or any of its excipients
- History of fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain
- Second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator
- History of alcoholism or drug abuse
- Consume more than 14 units of alcohol a week
- Significant infection or known inflammatory process on 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
- Use of medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion
- Have donated or received any blood or blood products within the 3 months prior to screening
- Vegetarians, vegans or have other medical dietary restrictions
- Cannot 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, is pregnant or breast-feeding
- If female, is of childbearing potential and does not use an approved effective contraceptive method (double-barrier method: 1 male barrier method \[male condom\] plus 1 female barrier method (diaphragm, spermicide, or intra-uterine device) or uses hormonal contraceptives
- Have received an investigational drug within 3 months of screening or is currently participating in another study
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00987558
Start Date
June 1 2009
End Date
August 1 2009
Last Update
January 13 2015
Active Locations (1)
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1
Biotrial, 7-9 rue Jean-Louis Bertrand
Rennes, France, F-35000