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

Completed

• Conditions: (zenuw) pijn bij diabetes en bij herpes (koortslip); neuralgia; neuropathic pain

• Registration Number: NL-OMON37431
• Lead Sponsor: Daiichi Pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics: several cognitive tests<br /><br>Pharmacokinetics: plasma DS-5565 and zolpidem concentrations, pharmacokinetic<br /><br>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>n/a</p><br>