Status:
COMPLETED
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00971295
Start Date
October 1 2007
End Date
September 1 2008
Last Update
December 16 2014
Active Locations (1)
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1
Human Pharmacology Unit (UFH)Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA,
Mamede Do Coronado, Portugal