Status:
COMPLETED
Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Epilepsy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a w...
Detailed Description
Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were ...
Eligibility Criteria
Inclusion
- Male or female subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG at screening.
- Subjects who had clinical laboratory tests clinically acceptable at screening.
- Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
- Subjects who were negative for alcohol and drugs of abuse at screening.
- Subjects who were non-smokers or who smoke less than 10 cigarettes or equivalent per day.
- Subjects who were 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: doublebarrier, intra-uterine device or abstinence.
- (If female) She had a negative pregnancy test at screening and admission to each study period.
Exclusion
- Subjects who do not conform to the above inclusion criteria, or
- Subjects who have 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 have a clinically relevant surgical history.
- Subjects who have a clinically relevant family history.
- Subjects who have a history of relevant atopy.
- Subjects who have a history of any drug hypersensitivity.
- Subjects who have a history of alcoholism or drug abuse.
- Subjects who consume more than 14 units of alcohol a week.
- Subjects who have a significant infection or known inflammatory process on screening and/or first admission.
- Subjects who have acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who have used medicines within 2 weeks of admission to first period.
- Subjects who have participated in any clinical trial within 3 months prior to screening.
- Subjects who have previously received BIA 2-093.
- Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to screening.
- Subjects who are vegetarians, vegans and/or have medical dietary restrictions.
- Subjects who cannot communicate reliably with the investigation team.
- Subjects who are unlikely to co-operate with the requirements of the study.
- Subjects who are unwilling or unable to give written informed consent.
- (If female) She is pregnant or breast-feeding.
- (If female) She is of childbearing potential and she does not use an approved effective contraceptive method or she uses oral contraceptives.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02279667
Start Date
February 1 2004
End Date
March 1 2004
Last Update
January 1 2015
Active Locations (1)
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1
CEB - Centre for Bioavailability Studies, AIBILI
Azinhaga de Santa Comba - Celas, Coimbra District, Portugal