Bioavailability Study of BIA 5-453

Last updated: March 20, 2017
Sponsor: Bial - Portela C S.A.
Overall Status: Completed

Phase

1

Condition

Congestive Heart Failure

Heart Failure

Stress

Treatment

N/A

Clinical Study ID

NCT03090568
BIA-5453-104
  • Ages 18-45
  • Male
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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, vitalsigns, 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 admissionto the first treatment period.

  • had negative screen for alcohol and drugs of abuse at screening and admission to thefirst treatment period.

  • were non-smokers or smoked ≤ 10 cigarettes or equivalent per day.

  • was able and willing to give written informed consent.

Exclusion

Exclusion Criteria:

  • had a clinically relevant history or presence of respiratory, gastrointestinal, renal,hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric,musculoskeletal, genitourinary, immunological, dermatological, endocrine, connectivetissue 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 tothe first treatment period.

  • had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) atthe time of screening or admission to the first treatment period.

  • used medicines within 2 weeks of admission to first period that affected the safety orother study assessments, in the investigator's opinion.

  • used any investigational drug or participated in any clinical trial within 3 monthsprior 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 toscreening.

  • 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

Total Participants: 12
Study Start date:
July 15, 2008
Estimated Completion Date:
August 14, 2008

Study 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.

Connect with a study center

  • Biotrial's Human Pharmacology Unit

    Rennes, F-35000
    France

    Site Not Available

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