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

In previous studies in healthy volunteers, this 2mg/24h patch is considered
well tolerated. The use of higher doses of rotigotine in healthy subjects is
limited by tolerability issues, eg, nausea and vomiting. With the dose used in
this study no serious adverse effects are expected. However, the possibility
that any adverse effects could occur cannot be entirely excluded.

Primary:
To evaluate the feasibility of using unconjugated rotigotine saliva
concentrations as a surrogate for unconjugated rotigotine plasma concentrations.

Secondary :
To evaluate the effect of time of food intake on rotigotine concentrations in
saliva

Design:
an open-label, randomized, two-way crossover study in fourteen healthy male
subjects each receiving a rotigotine transdermal patch, for twenty-four hours,
over a treatment period of seven days; subjects will be randomized to breakfast
sequence early-late or late-early on Days 6 and 7

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 patch

Treatments
a transdermal patch for 24 hours applied once daily on days 1-7, containing 4.5
mg rotigotine/10 cm2 (2mg/24h)

Not applicable.