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.
Completed
- Conditions
- Type 2 Diabetes Mellitus.10018424
- Registration Number
- NL-OMON34715
- Lead Sponsor
- Astellas Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
- Between 18 and 55 years of age
- BMI between 18.5 and 30.0 kg/m2
- Not a heavy smoker
Exclusion Criteria
An important medical disorder, hepatitis B, cancer or HIV/AIDS detected during screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p><br /><br>Pharmacodynamics: glucose and creatinine concentrations in urine<br /><br>Pharmacokinetics: study drug and glimepiride concentrations in plasma,<br /><br>pharmacokinetic parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>
- Secondary Outcome Measures
Name Time Method <p>nvt</p><br>