Phase
Condition
Congestive Heart Failure
Heart Failure
Stress
Treatment
N/AClinical Study ID
Ages 18-45 Male Accepts Healthy Volunteers
Study Summary
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
Study Description
Connect with a study center
Biotrial's Human Pharmacology Unit
Rennes, F-35000
FranceSite Not Available
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