A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol
A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.
1 other identifier
interventional
30
1 country
1
Brief Summary
This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Feb 2010
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 8, 2010
CompletedJune 9, 2010
June 1, 2010
2 months
March 30, 2010
June 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples
For 72 hours after each administration
Study Arms (1)
one group
EXPERIMENTALSubjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Kantou, Japan
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 30, 2010
First Posted
April 8, 2010
Study Start
February 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
June 9, 2010
Record last verified: 2010-06