Status:
COMPLETED
Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Single centre, open-label, randomised study in four parallel groups of healthy volunteers
Detailed Description
Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
- Subjects who had clinical laboratory tests clinically acceptable at screening and admission.
- Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
- Subjects who were negative for drugs of abuse and alcohol at screening and admission.
- Subjects who were non-smokers or who smoke \< 10 cigarettes or equivalent per day.
- Subjects who are able and willing to give written informed consent.
- (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
- (If female) She had a negative pregnancy test at screening and admission to Phase A.
- Exclusion Criteria:
- Subjects who did not conform to the above inclusion criteria, OR
- Subjects who had a 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.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
- Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).
- Subjects who had a history of alcoholism or drug abuse.
- Subjects who consumed more than 14 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening or admission.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02281591
Start Date
June 1 2006
End Date
July 1 2006
Last Update
April 8 2025
Active Locations (1)
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1
Scope International Life Sciences AG,
Hamburg, Germany, D-22525