A RANDOMIZED, DOUBLE-BLIND DRUG-DRUG INTERACTION STUDY TO ASSESS THE EFFECT OF ZOLPIDEM ON THE PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY AND TOLERABILITY OF DS-5565 IN HEALTHY SUBJECTS

A RANDOMIZED, DOUBLE-BLIND DRUG-DRUG INTERACTION STUDY TO ASSESS THE EFFECT OF ZOLPIDEM ON THE PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY AND TOLERABILITY OF DS-5565 IN HEALTHY SUBJECTS - DS-5565 zolpidem interaction study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37431

Enrollment

Registered

2012-02-06

Start date

2012-02-14

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

(zenuw) pijn bij diabetes en bij herpes (koortslip) neuralgia neuropathic pain

Interventions

This study consists of 4 periods, during each period you will receive DS-5565 or placebo at a single dose of 10 mg for 3 occasions (as a morning and evening dose on Day 1 and as a morning dose on Da

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female (negative pregnancy test) Age: 18-55 years (inclusive) BMI: 19.0 - 30.0 (inclusive)

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/Aids. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters blood in the 10 months preceding the start of the study.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics: several cognitive tests Pharmacokinetics: plasma DS-5565 and zolpidem concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)