Investigation of the impact of sarizotan on the pharmacokinetics of levodopa.
BIOPHARMACEUTICS & DRUG DISPOSITION(2007)
Abstract
Objective. To investigate the effect of sarizotan on the pharmacokinetics of levodopa in fixed combination with carbidopa or benserazide. Methods. In this open-label, randomized, crossover study, healthy male subjects (n = 16) received levodopa 100 mg t.i.d. over two 5-day periods, alone or in combination with sarizotan 5 mg b.i.d. Levodopa was administered with a dopa-decarboxylase inhibitor (carbidopa 25 mg, n = 8 or benserazide 25 mg, n = 8). Pharmacokinetic parameters of levodopa were obtained on days 1 and 5. Results. ANOVA showed the C-max values for levodopa were not significantly different with or without sarizotan after single doses (1001 vs 1082 ng/ml; point estimate [PE] 1.10, 90% confidence intervals [CI] 0.83-1.45) or at steady-state (1549 vs 1663 ng/ml; PE 1.06, 90% CI 0.89-1.27); nor were AUC values for single doses (1661 vs 1665 ngh/ml; PE 1.01, 90% CI 0.91-1.11) or at steady-state (2462 vs 2482 ng h/ml; PE 1.01, 90% CI 0.97-1.05). Seven subjects reported adverse events of mild-to-moderate intensity; the most frequent were headaches and dizziness. Conclusion. Coadministration of sarizotan with levodopa, in combination with a dopa-decarboxylase inhibitor had no effect on the pharmacokinetics or adverse event profile of levodopa. Copyright (C) 2007 John Wiley & Sons, Ltd.
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Key words
sarizotan,drug-drug interactions,levodopa
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