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This Article Full Text Full Text (PDF) All Versions of this Article: 0091270009338481v1 49/9/1047    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Google Scholar Articles by Braun, M. Articles by Horstmann, R. PubMed PubMed Citation Articles by Braun, M. Articles by Horstmann, R. Social Bookmarking                         What's this?

Lack of Pharmacokinetic Interactions Between Transdermal Rotigotine and Oral Levodopa/Carbidopa

From Schwarz Biosciences GmbH, UCB-Group, Monheim, Germany.

This open-label phase I trial assessed potential pharmacokinetic interactions between oral levodopa/carbidopa and transdermal rotigotine treatment at steady state. Twenty-four participants with idiopathic restless legs syndrome (12 per group) received levodopa/carbidopa (100 mg/25 mg bid) and rotigotine (initial dose 2 mg/24 h for 3 days, followed by 4 mg/24 h) in a randomized sequence as monotherapy and in combination during hospitalization for 13 days. Primary pharmacokinetic parameters were AUC_ss and C_max,ss of levodopa, carbidopa, and rotigotine at steady state. Mean concentration-time profiles of the 3 agents were similar during monotherapy and combination treatment. The point estimate for the ratio of geometric means (combined vs monotherapy) for AUC_ss and C_max,ss for levodopa (0.98 and 1.04), carbidopa (1.03 and 1.06), and unconjugated rotigotine (1.02 and 0.98) was near unity. All 90% confidence intervals were within the acceptance range for bioequivalence (0.8, 1.25). The most frequently documented adverse events were application site reactions (itching and reddening at application site) and headache. Most adverse events were mild to moderate in intensity, but 2 were of severe intensity (headache and extrasystoles); no serious adverse events occurred. The data presented indicate that rotigotine and levodopa/carbidopa can be coadministered without pharmacokinetic interactions between the compounds.

Key Words: Dopamine agonist • drug-drug interaction • levodopa/carbidopa • rotigotine • transdermal patch

Address for reprints: Marina Braun, MD, Global Exploratory Development, Schwarz Biosciences GmbH, Alfred Nobel Str. 10, 40789 Monheim, Germany; e-mail: Marina.Braun{at}ucb.com.

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