Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for RLS

This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.

Inclusion criteria:

• Patients with a diagnosis of RLS
• Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
• Normal blood pressure pre-study
• Light smokers only (<20/day)

Exclusion criteria:

• History of postural hypotension or faints
• Secondary RLS
• Patients who suffer from a primary sleep disorder other than RLS
• Patients diagnosed with movement disorders
• Patients with unstable medical conditions
• Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
• Patients with abnormal laboratory values
• Patients with hepatitis or HIV
• Patients who abuse alcohol or drugs
• Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa