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.

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. - study drug/glimepiride interaction study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34715

Enrollment

Registered

2009-12-15

Start date

2010-01-17

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Type 2 Diabetes Mellitus.

Interventions

Part A Treatment 1: an oral dose of glimepiride on Days 1 and 8 and an oral dose of study drug once daily on Days 4-10 Treatment 2: an oral dose of glimepiride on Days 5 and 10 and an oral dose of

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Between 18 and 55 years of age - BMI between 18.5 and 30.0 kg/m2 - Not a heavy smoker

Exclusion criteria

Exclusion criteria: An important medical disorder, hepatitis B, cancer or HIV/AIDS detected during screening.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics: glucose and creatinine concentrations in urine Pharmacokinetics: study drug and glimepiride concentrations in plasma, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)