Details

Autor(en) / Beteiligte

• Dingemanse, J.
• Kleinbloesem, C.H.
• Crevoisier, Ch
• Lankhaar, G.
• Gasser, U.E.

Titel

Pharmacokinetic Studies with a Dual-Release Formulation of Levodopa, a Novel Principle in the Treatment of Parkinson’s Disease

Ist Teil von

• European neurology, 1998-01, Vol.39 (2), p.119-124

Ort / Verlag

Basel, Switzerland: Karger

Erscheinungsjahr

1998

Quelle

MEDLINE

Beschreibungen/Notizen

• The objectives of the two studies reported here were the investigation of the influence of tablet breaking and food on the pharmacokinetics of levodopa and 3-O-methyldopa (3-OMD) after administration of a new levodopa/benserazide formulation with a biphasic drug delivery profile (Madopar ® DR). Both studies had an open-label, randomised, two-way crossover design and were conducted in 12 healthy young subjects. The pharmacokinetics of levodopa and 3-OMD after one intact or two halved tablets were very similar with average C max and t max 1.9 mg·l –1 and 1.2 h, respectively. Administration of the formulation after a standard breakfast did not influence the extent of levodopa absorption but increased the absorption rate. C max and t max were on average 2.1 mg·l –1 and 1.3 h, respectively, in the fed condition and 1.5 mg·l –1 and 2.5 h in the fasted condition. The presence of food did not markedly affect the plateau in levodopa levels between about 1 and 3 h after intake. In conclusion, the release characteristics in healthy subjects of the new levodopa/benserazide formulation are influenced only to a minor extent by concomitant intake of food or by tablet breaking.