A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mirabegron

Criteria

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