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Br J Clin Pharmacol. 2005 Apr;59(4):479-82.

Raloxifene pharmacokinetics in males with normal and impaired renal function.

Author information

1
University Hospital Ulm, Division of Nephrology, Ulm, Germany.

Abstract

AIMS:

To compare raloxifene pharmacokinetics between renally impaired and healthy subjects.

METHODS:

Raloxifene 120 mg was administered to 10 males with renal impairment (creatinine 2-4 mg dl(-1)) and to 10 healthy males. Data were analysed by two noncompartmental and one compartmental nonlinear regression methods.

RESULTS:

The medians (95% confidence interval) of the area under the curves (AUC) were 35.1 (25.8, 74) and 20.5 (16.8, 28.0) h ng ml(-1) per mg kg(-1), P < 0.01, and of the clearances (CL/F) were 28.5 (13.5, 38.8) and 48.8 (35.8, 59.4) l h(-1) kg(-1), P < 0.01, in renally impaired and healthy subjects, respectively. 95% Confidence intervals on the differences for AUC and CL/F were 6.5-44.1 and -35.1 to -7.9, respectively.

CONCLUSION:

Exposure to raloxifene was twice as high in males with renal impairment compared with healthy subjects.

PMID:
15801944
PMCID:
PMC1884804
DOI:
10.1111/j.1365-2125.2004.02326.x
[Indexed for MEDLINE]
Free PMC Article

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