Bioavailability Study of BIA 5-453
- Registration Number
- NCT03090568
- Lead Sponsor
- Bial - Portela C S.A.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BIA 5-453 Fed BIA 5-453 BIA 5-453 200 mg in fed conditions BIA 5-453 Fasting BIA 5-453 BIA 5-453 200 mg in fasting conditions
- Primary Outcome Measures
Name Time Method Tmax - the time of occurrence of Cmax 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 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose AUC0-∞ - the area under the plasma concentration versus time curve from time zero to infinity 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 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Biotrial's Human Pharmacology Unit
🇫🇷Rennes, France