healthy adult healthy adult
Conditions
Interventions
Registered study subjects will receive a continuous intravenous infusion of raniridol at a dose of 20.0micro/kg/min for 60 minutes. All subjects will receive the same dose and undergo the observations
Landiolol, heart rate response
Sponsors
Shiga Tsuyoshi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following selection criteria: Japanese or Caucasian healthy adults who have given their consent. 1) Race: Japanese or Caucasian 2) Gender: Male 3) Age: 30 to 55 years old 4) Weight: 40 to 90 kg 5) BMI: 18.5 to 30 6) Blood pressure (supine): Systolic blood pressure of 100 mmHg or higher and 139 mmHg or lower 7) Resting heart rate (sinus rhythm) of 60 beats per minute or higher on a 12-lead electrocardiogram performed on the day of consent acquisition 8) Individuals who have received sufficient explanation regarding participation in the study, have a full understanding of the study, and have provided written consent of their own free will.
Exclusion criteria
Exclusion criteria: 1) Individuals with hypersensitivity or idiosyncrasy to the test drug 2) Individuals with a history of central nervous system, cardiovascular system, respiratory system, hematopoietic function, gastrointestinal system, liver or kidney dysfunction, thyroid dysfunction, or drug-induced gastrointestinal disorders, or individuals currently requiring treatment for such conditions (except those deemed eligible for participation by the principal investigator or sub-investigator) 3) Individuals with a history of fainting 4) Individuals who have had more than 200 mL of blood drawn within one month prior to administration of the test drug 5) Individuals who have had more than 400 mL of blood drawn within three months prior to administration of the test drug, or who have donated blood components within two weeks prior to administration of the test drug 6) Individuals who have participated in and received administration of a Phase I clinical trial of a new active ingredient-containing drug within four months prior to administration of the test drug, or who have participated in and received administration of a clinical trial of an already approved drug within three months prior to administration of the test drug 7) Alcohol or drug dependent individuals 8) Other individuals deemed inappropriate by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in heart rate from resting state (sitting) before exercise to peak state | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak heart rate during exercise load,Change in the rate-pressure product (heart rate multiplied by systolic blood pressure) from pre-exercise rest to peak exercise,Resting heart rate in the supine position,Change in heart rate during head-up tilt load, Change in the rate-pressure product (heart rate multiplied by systolic blood pressure) from pre-tilt to near the end of the tilt load, Plasma norepinephrine concentration at rest and at the end of exercise during bicycle ergometer exercise load | — |
Contacts
Public ContactTsuyoshi Shiga
The Jikei University School of Medicine
Outcome results
None listed