Status:
COMPLETED
A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers
Detailed Description
Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, ...
Eligibility Criteria
Inclusion
- Male 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 within normal ranges 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 smoked less than 10 cigarettes or equivalent per day.
- Subjects who were able and willing to give written informed consent.
Exclusion
- 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.
- 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.
- Subjects who had acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who had used prescription or over-the-counter medication within 2 weeks of admission.
- Subjects who had used any investigational drug or participated in any clinical trial within 3 months of admission.
- Subjects who had previously received BIA 2-093.
- Subjects who had donated or received any blood or blood products within the previous 3 months prior to screening.
- Subjects who were vegetarians, vegans or had medical dietary restrictions.
- Subjects who could not communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01879345
Start Date
October 1 2004
End Date
December 1 2004
Last Update
April 8 2025
Active Locations (1)
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1
Human Pharmacology Unit - BIAL - Portela & Ca, S.A.
Trofa, Coronado (S.Romão E S. Mamede), Portugal, 4745-457