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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03095092 |
Date of registration:
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23/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of Food on BIA 6-512 (Trans-resveratrol)
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Scientific title:
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The Effect of Food on the Pharmacokinetics of a Single 400 mg Oral Dose of BIA 6-512 (Trans-resveratrol) in Healthy Subjects |
Date of first enrolment:
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May 23, 2005 |
Target sample size:
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24 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03095092 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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 30 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical
examination, vital signs, and 12-lead ECG.
- Subjects who had clinical laboratory test results clinically acceptable at screening
and admission to first treatment period.
- Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at
screening.
- Subjects who had a negative screen for alcohol and drugs of abuse at screening and
admission to each treatment period.
- Subjects who were non-smokers or who smoke = 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: double
barrier, intrauterine device or abstinence.
- (If female) She had a negative urine pregnancy test at screening and admission to each
treatment period.
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 drug or food hypersensitivity.
- Subjects who had a history of alcoholism or drug abuse.
- Subjects who consumed more than 21 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening or
first admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening or first
admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who had used medicines within 2 weeks of first admission that, in the opinion
of the investigator, may affect the safety or other study assessments.
- Subjects who had used any investigational drug or participated in any clinical trial
within 2 months of their first admission.
- Subjects who had donated or received any blood or blood products within the previous 2
months prior to screening.
- Subjects who were vegetarians, vegans or have medical dietary restrictions.
- Subjects who cannot communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- Subjects who were unwilling or unable to give written informed consent.
- (If female) She was pregnant or breast-feeding.
- (If female) She was of childbearing potential and she did not use and approved
effective contraceptive method (double-barrier, intra-uterine device or abstinence) or
she used 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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Parkinson Disease
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Intervention(s)
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Drug: BIA 6-512 400 mg
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Primary Outcome(s)
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AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule
[Time Frame: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]
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Cmax - the maximum plasma concentration;
[Time Frame: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]
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tmax - the time of occurrence of Cmax
[Time Frame: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]
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Secondary ID(s)
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BIA-6512-104
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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