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• W2029042847 abstract "It has been reported that pomegranate juice significantly increased the AUC of orally administered carbamazepine in rats, which suggests that pomegranate may inhibit the cytochrome P450 3A (CYP3A)-mediated carbamazepine metabolism.The aim of the present study was to clarify the effect of repeated consumption of pomegranate juice on CYP3A activity by assessing the pharmacokinetics of midazolam, a typical CYP3A probe drug, and its metabolites in healthy volunteers.An open-label, randomized, single-center, 2-period crossover study was conducted on healthy Japanese volunteers. Each subject received 200 mL of pomegranate juice twice daily for 2 weeks. On day 14, they were administered 15 μg/kg midazolam orally with either pomegranate juice or water. Plasma concentrations and urinary excretions of midazolam, 1'-hydroxymidazolam, and 4-hydroxymidazolam were determined up to 24 hours using LC/MS/MS and analyzed by a noncompartmental method.Sixteen subjects (11 men and 5 women) were enrolled and completed the study. The mean (SD) age was 24.1 (4.8) years (range 22-40), mean body weight was 62.9 (8.8) kg (range 45.6-79.9). Differences in the mean AUC(0-∞) were 12.7 (4.4) and 14.2 (6.6) ng/mL/h in pomegranate juice and control groups, respectively (geometric mean ratio: 1.02 [95% CI, 0.95-1.09]; P = 0.40). Differences in C(max) for midazolam did not reach the level of statistical significance (5.1 [1.7] vs 5.0 [2.0] ng/mL, geometric mean ratio: 0.95 [95% CI, 0.79-1.11]; P = 0.68). Excretions of 1'-hydroxymidazolam (P = 0.34) and 4-hydroxymidazolam (P = 0.32) were not significantly altered by ingestion of pomegranate juice.In this small Japanese adult volunteer population receiving single subtherapeutic doses of midazolam, 2 weeks' consumption of pomegranate juice did not significantly alter the pharmacokinetic profile of midazolam compared with that of the control. Protocol identifier: UMIN000004459." @default.
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• W2029042847 date "2011-02-01" @default.
• W2029042847 modified "2023-10-16" @default.
• W2029042847 title "Effect of 2 Weeks' Consumption of Pomegranate Juice on the Pharmacokinetics of a Single Dose of Midazolam: An Open-Label, Randomized, Single-Center, 2-Period Crossover Study in Healthy Japanese Volunteers" @default.
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• W2029042847 doi "https://doi.org/10.1016/j.clinthera.2011.02.012" @default.
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