A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration

Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01403818

Enrollment

Registered

2011-07-27

Start date

2011-06-30

Completion date

2011-08-31

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Pharmacokinetics of ASP1941, Pharmacokinetics of Mitiglinide

Keywords

ASP1941, ipragliflozin, Mitiglinide calcium hydrate, Drug-Drug interaction, Pharmacokinetics

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 them after separate and concomitant administration to healthy non-elderly adult male subjects.

Interventions

DRUGASP1941

oral

DRUGMitiglinide calcium hydrate

oral

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 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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change	For up to 72 hours after each administration

Secondary

Measure	Time frame
Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests	For up to 10 days
Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change	For 72 hours after ASP1941 administration

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026