Japanese healthy male subjects
Conditions
Interventions
investigational material(s)
Generic name etc : NMB46
INN of investigational material : Regadenoson
Therapeutic category code : 799 Agents for not mainly purpose of therapeutic, n.e.c.
Dosage and Admin
Sponsors
Nihon Medi-Physics Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Body weight: between 50 and 90 kg, Body Mass Index: between 18 and 28 at the screening examination. (2) Normal ECG at screening and Day -1 or an abnormal ECG not considered clinically significant. (3) Normal arterial blood pressure (BP) and heart rate (HR). These will be measured after resting supine for 3 minutes at screening and Day -1.
Exclusion criteria
Exclusion criteria: (1) Administration of any investigational drug in the period 0 to 12 weeks before Day -1 (0 to 16 weeks if the previous investigational drug was a new chemical entity). (2) Existence of any surgical or medical condition which, in the judgement of the clinical investigator or sub-investigators, might interfere with the absorption, distribution, metabolism or excretion of regadenoson. (3) Prior history of syncope, migraine headaches or coronary artery disease. (4) Prior history or complications of bronchial asthma or chronic obstructive pulmobnary disease. (5) Prior or family history of long QT syndorome. (6) Serious adverse reaction or hypersensitivity to any drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse Events, Laboratory tests, Vital signs, ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Concentration of regadenoson in Plasma Excretion of regadenoson in Urine | — |
Countries
Japan
Outcome results
None listed