Congestive Heart Failure, Hypertension
Conditions
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.
Interventions
DRUGBIA 5-453
BIA 5-453 capsules 50 mg. Route of administration: Oral. In one period subjects received 4 capsules of 50 mg of BIA 5-453 after a fasting of at least 10 hours, and in the other period subjects were dosed with 4 capsules of 50 mg of BIA 5-453 after a standard high-fat and high-calorie meal
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
France
Outcome results
None listed