Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity
Study Overview
Brief Summary
The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.
Detailed Description
This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers. Subjects received a single oral 200 mg dose of BIA 5-453 following a standard meal in one period, and following at least 10 hours of fasting in another period. Treatment periods were separated by a washout interval of 2 weeks or more.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •aged between 18 and 45 years, inclusive.
- •had a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- •were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
- •had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
- •had clinical laboratory test results clinically acceptable at screening and admission to the first treatment period.
- •had negative screen for alcohol and drugs of abuse at screening and admission to the first treatment period.
- •were non-smokers or smoked ≤ 10 cigarettes or equivalent per day.
- •was able and willing to give written informed consent.
Exclusion Criteria
- •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.
- •had a clinically relevant surgical history.
- •had a clinically relevant family history.
- •had a history of relevant atopy or drug hypersensitivity.
- •had a history of alcoholism or drug abuse.
- •consumed more than 14 units of alcohol a week.
- •had a significant infection or known inflammatory process at screening or admission to the first treatment period.
- •had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the first treatment period.
- •used medicines within 2 weeks of admission to first period that affected the safety or other study assessments, in the investigator's opinion.
- •used any investigational drug or participated in any clinical trial within 3 months prior to screening.
- •participated in more than 2 clinical trials within the 12 months prior to screening.
- •donated or received any blood or blood products within the 3 months prior to screening.
- •was a vegetarian, vegan or with medical dietary restrictions.
- •could not communicate reliably with the investigator.
- •was unlikely to co-operate with the requirements of the study.
- •was unwilling or unable to give written informed consent.
Arms & Interventions
BIA 5-453 Fasting
BIA 5-453 200 mg in fasting conditions
Intervention: BIA 5-453 (Drug)
BIA 5-453 Fed
BIA 5-453 200 mg in fed conditions
Intervention: BIA 5-453 (Drug)
Outcomes
Primary Outcomes
AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity
Time Frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Tmax - the time of occurrence of Cmax
Time Frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
Time Frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Cmax - the maximum plasma concentration
Time Frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
Secondary Outcomes
No secondary outcomes reported