Bioavailability Study of BIA 5-453 | NCT03090568

NCT03090568

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIA 5-453 Fasting	Experimental	BIA 5-453 200 mg in fasting conditions	Drug: BIA 5-453
BIA 5-453 Fed	Experimental	BIA 5-453 200 mg in fed conditions	Drug: BIA 5-453

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIA 5-453	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	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

Eligibility Module

Eligibility Criteria

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.

ID	Term
D006973	Hypertension
D006333	Heart Failure