Keith Gallicano1, Brian Foster, Shurjeel Choudhri. 1. Clinical Investigation Unit, The Ottawa Hospital-General Campus, Health Canada, Ottawa, Ontario, Canada. kgallicano@axelson.net
Abstract
AIMS: To evaluate the effect of acute dosing of garlic supplements on the single-dose pharmacokinetics of ritonavir. METHODS:Ten healthy volunteers (five male, five female) were equally randomized in a crossover design to receive 400 mg of a single dose of ritonavir within 10 min after eating breakfast either alone or with 10 mg of Natural Source Odourless Garlic. They received a total of eight doses of garlic extract (2 x 5 mg capsules) taken twice daily for 4 days. Ritonavir and the seventh garlic dose were administered simultaneously. RESULTS: Coadministration of garlic nonsignificantly decreased area under the plasma concentration-time curve (AUC(0, infinity )) by -17% (90% confidence interval (CI), -31% to 0%; range -46% to 68%) and peak plasma concentration of ritonavir by -1% (90% CI, -25% to 31%; range -51% to 136%). CONCLUSIONS: Acute dosing of the garlic capsules over 4 days did not significantly alter the single-dose pharmacokinetics of ritonavir in healthy volunteers. Given the complex effects of both ritonavir and garlic on drug metabolism, the results of our study should not be extrapolated to steady-state conditions, where the possibility of an interaction still needs to be evaluated.
RCT Entities:
AIMS: To evaluate the effect of acute dosing of garlic supplements on the single-dose pharmacokinetics of ritonavir. METHODS: Ten healthy volunteers (five male, five female) were equally randomized in a crossover design to receive 400 mg of a single dose of ritonavir within 10 min after eating breakfast either alone or with 10 mg of Natural Source Odourless Garlic. They received a total of eight doses of garlic extract (2 x 5 mg capsules) taken twice daily for 4 days. Ritonavir and the seventh garlic dose were administered simultaneously. RESULTS: Coadministration of garlic nonsignificantly decreased area under the plasma concentration-time curve (AUC(0, infinity )) by -17% (90% confidence interval (CI), -31% to 0%; range -46% to 68%) and peak plasma concentration of ritonavir by -1% (90% CI, -25% to 31%; range -51% to 136%). CONCLUSIONS: Acute dosing of the garlic capsules over 4 days did not significantly alter the single-dose pharmacokinetics of ritonavir in healthy volunteers. Given the complex effects of both ritonavir and garlic on drug metabolism, the results of our study should not be extrapolated to steady-state conditions, where the possibility of an interaction still needs to be evaluated.
Authors: Stephen C Piscitelli; Aaron H Burstein; Nada Welden; Keith D Gallicano; Judith Falloon Journal: Clin Infect Dis Date: 2001-12-05 Impact factor: 9.079
Authors: B C Foster; M S Foster; S Vandenhoek; A Krantis; J W Budzinski; J T Arnason; K D Gallicano; S Choudri Journal: J Pharm Pharm Sci Date: 2001 May-Aug Impact factor: 2.327
Authors: Edward Mills; Kumanan Wilson; Mike Clarke; Brian Foster; Scott Walker; Beth Rachlis; Nick DeGroot; Victor M Montori; Wayne Gold; Elizabeth Phillips; Stephen Myers; Keith Gallicano Journal: Eur J Clin Pharmacol Date: 2005-01-22 Impact factor: 2.953
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