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Br J Clin Pharmacol. 2007 Oct;64(4):469-75. Epub 2007 May 15.

Effects of Schisandra sphenanthera extract on the pharmacokinetics of tacrolimus in healthy volunteers.

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  • 1Department of Clinical Pharmacology, Wuhan General Hospital, Wuhan, China.

Abstract

AIM:

To assess the effect of Schisandra sphenanthera extract (SchE) on the pharmacokinetics of tacrolimus in healthy volunteers.

METHODS:

Twelve healthy male volunteers were orally treated with SchE, three capsules twice daily for 13 days. Pharmacokinetic investigations of oral tacrolimus administration at 2 mg were performed both before and at the end of the SchE treatment period. Whole blood tacrolimus concentrations were determined by enzyme-linked immunosorbent assay. Estimated pharmacokinetic parameters before and with SchE were calculated with noncompartmental techniques.

RESULTS:

Following administration of SchE, the average percentage increases of individual increases in AUC, AUMC and C(max) of tacrolimus were 164.2% [95% confidence interval (CI) 70.1, 258.4], 133.1% (95% CI 49.5, 261.3) and 227.1% (95% CI 155.8, 298.4), respectively (P < 0.01 or 0.05). On average, there was a 36.8% (95% CI 13.4, 60.2) increase in tacrolimus t(max) (P < 0.01). The average percentage decreases in CL/F and V/F were 49.0% (95% CI 31.1, 66.9) and 53.7% (95% CI 40.1, 67.4), respectively (P < 0.01).

CONCLUSIONS:

SchE can increase the oral bioavailability of tacrolimus. The results of this study will add important information to the interaction area between drugs and herbal products.

PMID:
17506780
[PubMed - indexed for MEDLINE]
PMCID:
PMC2048562
Free PMC Article

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