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Drug-drug Interaction Study With ASP1941 and Glimepiride

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302158
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
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.
Information provided by:
Astellas Pharma Inc
  Purpose
A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

Condition Intervention Phase
Healthy Subjects Drug: ASP1941 Drug: Glimepiride Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized Crossover Study to Evaluate the Effect of ASP1941 on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glimepiride in Healthy Subjects and Vice Versa

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941 [ Time Frame: 14 days ]

Enrollment: 52
Study Start Date: December 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ASP1941
    oral
    Drug: Glimepiride
    oral
Detailed Description:
Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 18.5 and 30 kg/m2, inclusive

Exclusion Criteria:

  • Any of the liver function tests above the upper limit of normal
  • Pulse <40 or >90 bpm; Systolic Blood Pressure >140 mmHg; Diastolic Blood Pressure > 90 mmHg
  Contacts and Locations
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): NCT01302158


Locations
Netherlands
Groningen, Netherlands, 9470 AE
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT01302158     History of Changes
Other Study ID Numbers: 1941-CL-0059
2009-013172-50 ( EudraCT Number )
First Submitted: February 21, 2011
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
Last Verified: February 2011

Keywords provided by Astellas Pharma Inc:
Drug-Drug interaction
ASP1941
Glimepiride
Healthy subjects

Additional relevant MeSH terms:
Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors