Kantou, Japan
NCT Number: NCT01403818
A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration
This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.
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Notify MeKey information
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, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.
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 kg/m2
- 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 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
Treatment and study plan
ASP1941
Drugoral
Other names: ipragliflozin
Mitiglinide calcium hydrate
Drugoral
Other names: Glufast
Primary outcomes
-
Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change
Time frame: For up to 72 hours after each administration
Secondary outcomes
-
Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
Time frame: For up to 10 days
-
Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change
Time frame: For 72 hours after ASP1941 administration
Sponsors and collaborators
Lead sponsor
Astellas Pharma Inc
Industry
Registry information
Official study title
Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jul 27, 2011
- Registry last updated
- Oct 12, 2011
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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