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Pharmacokinetic and safety profile of trans-resveratrol in a rising multiple-dose study in healthy volunteers

Title
Pharmacokinetic and safety profile of trans-resveratrol in a rising multiple-dose study in healthy volunteers
Type
Article in International Scientific Journal
Year
2009
Authors
Almeida, L
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Vaz Da Silva, M
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FMUP
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Falcao, A
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Soares, E
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Costa, R
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Loureiro, AI
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Fernandes Lopes, C
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Rocha, JF
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Nunes, T
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Wright, L
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soares-da-silva, p
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FMUP
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Journal
Vol. 53
Pages: S7-S15
ISSN: 1613-4125
Publisher: Wiley-Blackwell
Other information
Authenticus ID: P-003-KJ7
Abstract (EN): This was a double-blind, randomised, placebo-controlled study to investigate the pharmacokinetics and safety of trans-resveratrol. In four groups of ten healthy adult subjects ( five males and five females), two subjects were randomized to receive placebo and eight subjects to receive trans-resveratrol 25, 50, 100 or 150 mg, six times/day, for thirteen doses. Peak plasma concentrations of trans-resveratrol were reached at 0.8-1.5 h postdose. Following the 13th dose of trans-resveratrol 25, 50, 100 and 150 mg, mean peak plasma concentration (C(max)) was 3.89, 7.39, 23.1 and 63.8 ng/mL and mean area under the plasma concentration-time curve (AUC(0-tau)) was 3.1, 11.2, 33.0 and 78.9 ng . h/mL. Interindividual variability was high, with coefficients of variation >40%. Trans-resveratrol half-life was 1-3 h following single-doses and 2-5 h following repeated dosing. Trough (C(min)) concentrations were <= 1 ng/mL following 25 and 50 mg, 3 ng/mL following 100 mg and <10 ng/mL following 150 mg. Trans-resveratrol pharmacokinetics showed circadian variation. Adverse events were mild in severity and similar between all groups. In conclusion, repeated administration was well-tolerated but produced relatively low plasma concentrations of trans-resveratrol, despite the high doses and short dosing interval used. Bioavailability was higher after morning administration.
Language: English
Type (Professor's evaluation): Scientific
No. of pages: 9
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