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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02279667 |
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Date of registration:
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29/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
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Scientific title:
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Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093 in Healthy Volunteers |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02279667 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1
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Countries of recruitment
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Portugal
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Intervention(s)
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Drug: BIA 2-093
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Primary Outcome(s)
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Tmax - the Time of Occurrence of Cmax
[Time Frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose]
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AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time
[Time Frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose]
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Cmax - the Maximum Plasma Concentration
[Time Frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose]
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AUC0-8 - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
[Time Frame: Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose]
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Secondary ID(s)
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BIA-2093-109
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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