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Completed

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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Key information

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kantou, Japan

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

Drug

oral

Other names: ipragliflozin

Mitiglinide calcium hydrate

Drug

oral

Other names: Glufast

Primary outcomes

  1. 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

  1. Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests

    Time frame: For up to 10 days

  2. 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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