Status:
COMPLETED
A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Healthy
Pharmacokinetics of ASP1941
Eligibility:
MALE
20-44 years
Phase:
PHASE1
Brief Summary
This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.
Detailed Description
This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of th...
Eligibility Criteria
Inclusion
- 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 kg/m2
- Written informed consent has been obtained
Exclusion
- 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 d 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01403818
Start Date
June 1 2011
End Date
August 1 2011
Last Update
October 12 2011
Active Locations (1)
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1
Kantou, Japan