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CompletedNCT01099839Updated Jun 9, 2010

A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol

A Phase 1 interventional study of ASP1941 and Miglitol in Healthy Volunteers and Pharmacokinetics of ASP1941, sponsored by Astellas Pharma Inc. Completed at 1 site in Japan. Open to male participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-09.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
Male
01

Study summary

This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.

Read the detailed description

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".

02

Conditions studied

  • Healthy Volunteers
  • Pharmacokinetics of ASP1941

Keywords

  • ASP1941
  • Miglitol
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Male
Accepts 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
  • Written informed consent has been obtained

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    one group

    Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.

    Drug: ASP1941 · Drug: Miglitol

Interventions

  • DrugASP1941

    oral

  • DrugMiglitol

    oral

    Also known as: Seibule

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples

    Time frame: For 72 hours after each administration

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Study locations

1 site
  • Kantou, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01099839
Lead sponsor
Astellas Pharma Inc
First posted
Apr 8, 2010
Start date
Feb 2010
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Jun 9, 2010

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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