ParkinsonFranceV1, Main, Exploration, bibRecord, 003263

Effects of food on the pharmacokinetics of levodopa in a dual-release formulation

Identifieur interne : 003263 ( Main/Exploration ); précédent : 003262; suivant : 003264

Effects of food on the pharmacokinetics of levodopa in a dual-release formulation

Auteurs : Charles Crevoisier [Suisse] ; Patricia Zerr [France] ; Francoise Calvi-Gries [France] ; Turid Nilsen [Norvège]

Source :

European journal of pharmaceutics and biopharmaceutics [ 0939-6411 ] ; 2003.

RBID : Pascal:03-0380650

Descripteurs français

Pascal (Inist)
- Lévodopa, Antiparkinsonien, Interaction aliment médicament, Bensérazide, Pharmacocinétique, Homme, Parkinson maladie, Normal, Plasma sanguin, Dose unique, Voie orale, Randomisation, Absorption, Toxicité, Biodisponibilité, Association médicamenteuse, Interaction médicamenteuse.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Absorption, Antiparkinson agent, Benserazide, Bioavailability, Blood plasma, Drug combination, Drug interaction, Food drug interaction, Human, Levodopa, Normal, Oral administration, Parkinson disease, Pharmacokinetics, Randomization, Single dose, Toxicity.

Abstract

The objective was to assess the effect of food on the pharmacokinetics of levodopa and 3-O-methyldopa after administration of a new levodopa/benserazide formulation with a dual-release drug delivery profile (Madopar® DR). In an open-label, two-way cross-over study, 19 healthy volunteers who had fasted overnight were randomized to receive a single oral dose of levodopa/benserazide (200/50 mg) in the absence or presence of a standardized, high-fat breakfast, administered 30 min before drug administration. The treatment periods (fasting, non-fasting) were preceded by a baseline regimen of levodopa/benserazide (100/25 mg t.i.d. for 6 or 7 days). Blood samples were taken at specific times over a 12-hour period. Plasma concentrations of levodopa and 3-O-methyldopa were determined by high-performance liquid chromatography for pharmacokinetic evaluation. The parameter C_max of levodopa was significantly lower and t_max longer under postprandial conditions than under fasting conditions (mean C_max 1.41 vs. 2.09 mg^-1; mean t_max 3.1 vs. 1.0 h). With food, the area under the curve (AUC) of levodopa was equivalent to that following an overnight fast. Compared with volunteers who had fasted, food did not alter t_1/2. Estimates of C_max, t_max and AUC of 3-O-methyldopa under non-fasting conditions were not significantly different from those under fasting conditions. In conclusion, food decreases the rate of levodopa absorption, but had no effect on the systemic exposure to levodopa and the degree of 3-O-methyldopa formation. Standardization of levodopa/benserazide administration with respect to meal times is recommended.

Affiliations:

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to stream PascalFrancis, to step Checkpoint: 000D84
to stream Main, to step Merge: 003747
to stream Main, to step Curation: 003263

Le document en format XML

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<front><div type="abstract" xml:lang="en">The objective was to assess the effect of food on the pharmacokinetics of levodopa and 3-O-methyldopa after administration of a new levodopa/benserazide formulation with a dual-release drug delivery profile (Madopar® DR). In an open-label, two-way cross-over study, 19 healthy volunteers who had fasted overnight were randomized to receive a single oral dose of levodopa/benserazide (200/50 mg) in the absence or presence of a standardized, high-fat breakfast, administered 30 min before drug administration. The treatment periods (fasting, non-fasting) were preceded by a baseline regimen of levodopa/benserazide (100/25 mg t.i.d. for 6 or 7 days). Blood samples were taken at specific times over a 12-hour period. Plasma concentrations of levodopa and 3-O-methyldopa were determined by high-performance liquid chromatography for pharmacokinetic evaluation. The parameter C<sub>max</sub>
 of levodopa was significantly lower and t<sub>max</sub>
 longer under postprandial conditions than under fasting conditions (mean C<sub>max</sub>
 1.41 vs. 2.09 mg<sup>-1</sup>
; mean t<sub>max</sub>
 3.1 vs. 1.0 h). With food, the area under the curve (AUC) of levodopa was equivalent to that following an overnight fast. Compared with volunteers who had fasted, food did not alter t<sub>1/2</sub>
. Estimates of C<sub>max</sub>
, t<sub>max</sub>
 and AUC of 3-O-methyldopa under non-fasting conditions were not significantly different from those under fasting conditions. In conclusion, food decreases the rate of levodopa absorption, but had no effect on the systemic exposure to levodopa and the degree of 3-O-methyldopa formation. Standardization of levodopa/benserazide administration with respect to meal times is recommended.</div>
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	La maladie de Parkinson en France (serveur d'exploration)
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La maladie de Parkinson en France (serveur d'exploration)

Effects of food on the pharmacokinetics of levodopa in a dual-release formulation

Effects of food on the pharmacokinetics of levodopa in a dual-release formulation

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri