Healthy Volunteers, Pharmacokinetics of ASP1941
Conditions
Keywords
ASP1941, Miglitol
Brief summary
This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.
Detailed description
This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in healthy adult male volunteers. Each subject will receive ASP1941 alone, Miglitol alone and ASP1941 + Miglitol.
Interventions
DRUGASP1941
oral
DRUGMiglitol
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests * Body weight ; ≥50.0 kg, \<80.0 kg * Body Mass Index ; ≥17.6, \<26.4 * Written informed consent has been obtained
Exclusion criteria
* Received any investigational drugs within 120 days before the screening assessment * 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 assessment * Received medication within 7 days before hospital admission * A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission * History of drug allergies * With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases * Previous treatment with ASP1941
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples | For 72 hours after each administration |
Countries
Japan
Outcome results
None listed