Bioavailability Study of BIA 5-453

Hypertension Clinical Trial

Official title:

Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090568
• Other study ID #: BIA-5453-104
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2017
• Last updated: March 20, 2017
• Start date: July 15, 2008
• Est. completion date: August 14, 2008

Study information

• Verified date: March 2017
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 14, 2008
• Est. primary completion date: August 14, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Hypertension

Intervention

Drug:
• BIA 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

Locations

Country	Name	City	State
France	Biotrial's Human Pharmacology Unit	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	AUC0-8 - 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