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

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 - Rotigotine transdermal patch study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35531

Enrollment

Registered

2011-08-29

Start date

2011-10-04

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

Parkinson's Disease restless legs

Interventions

Study Medication Active substance: rotigotine Activity: nonergolinic dopamine D3/D2/D1 agonist Indication: parkinsons disease, restless legs syndrome Strength: 4.5 mg/10 cm2 Dosage form: transdermal

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: plasma and saliva rotigotine concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination, skin evaluation, C-SSRS	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)