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OpenTrials
Completed

NCT Number: NCT01302158

Drug-drug Interaction Study With ASP1941 and Glimepiride

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).

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Groningen, 9470 AE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP1941

Drug

oral

Glimepiride

Drug

oral

Primary outcomes

  1. Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride

    Time frame: 14 days

Secondary outcomes

  1. Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 23, 2011
Registry last updated
Feb 23, 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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