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Completed

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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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, 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

Drug

oral

Miglitol

Drug

oral

Other names: Seibule

Primary outcomes

  1. 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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