Healthy Volunteer, Pharmacokinetics of YM178
Conditions
Keywords
Overactive Bladder, Urinary incontinence, YM178, mirabegron
Brief summary
The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult subjects.
Interventions
DRUGYM178
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests * Body weight (at screening); female ≥40.0 kg, \<70.0 kg, male ≥50.0 kg, \<80.0 kg * BMI (at screening): ≥17.6, \<26.4 * Written informed consent has been obtained
Exclusion criteria
* Received any investigational drugs within 120 days before the screening test * Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening test * Received medication within 7 days before hospital admission or is scheduled to receive medication * Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period * History of drug allergies * Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before hospital admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of unchanged YM178 | Up to 96 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Urinary concentration of unchanged YM178 | Up to 96 hours post dose |
Countries
Japan
Outcome results
None listed