Drug-drug Interaction Study With ASP1941 and Glimepiride

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01302158

Enrollment

Registered

2011-02-23

Start date

2009-12-31

Completion date

2010-04-30

Last updated

2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Drug-Drug interaction, ASP1941, Glimepiride, Healthy subjects

Brief summary

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).

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.

Interventions

DRUGASP1941

oral

DRUGGlimepiride

oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride	14 days

Secondary

Measure	Time frame
Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941	14 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026