A single-site, open-label study in healthy male subjects to compare rotigotine saliva and plasma concentrations in steady-state after multiple-dose application of rotigotine transdermal patch

Completed

• Conditions: Parkinson's Disease; restless legs; 10028037

• Registration Number: NL-OMON35531
• Lead Sponsor: CB Pharma

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: 14

Inclusion Criteria

male; 18 - 25 years; BMI 19.0 - 28.0 kg/m2; no smoking; white skin.

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 3 months the screening for the study or being a blood donor within 3 months prior to the screening for the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics: plasma and saliva rotigotine concentrations, pharmacokinetic<br /><br>parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination, skin evaluation, C-SSRS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>