ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01099839
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : June 9, 2010
Sponsor:
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Pharmacokinetics of ASP1941 Drug: ASP1941 Drug: Miglitol Phase 1

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".

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.
Study Start Date : February 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Miglitol

Arm Intervention/treatment
Experimental: one group
Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.
Drug: ASP1941
oral

Drug: Miglitol
oral
Other Name: Seibule




Primary Outcome Measures :
  1. Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples [ Time Frame: For 72 hours after each administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099839


Locations
Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01099839     History of Changes
Other Study ID Numbers: 1941-CL-0062
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by Astellas Pharma Inc:
ASP1941
Miglitol

Additional relevant MeSH terms:
Miglitol
1-Deoxynojirimycin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Antiviral Agents
Anti-Infective Agents