Kantou, Japan
NCT Number: NCT01099839
A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol
This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.
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Notify MeKey information
Conditions
Age range
20 year–44 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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".
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ASP1941
Drugoral
Miglitol
Drugoral
Other names: Seibule
Primary outcomes
-
Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples
Time frame: For 72 hours after each administration
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Registry information
Official study title
A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.
Important dates
- Study start
- 2010
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Apr 8, 2010
- Registry last updated
- Jun 9, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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