Premium
Raloxifene pharmacokinetics in males with normal and impaired renal function
Author(s) -
Czock David,
Keller Frieder,
Heringa Mette,
Rasche Franz Maximilian
Publication year - 2005
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2004.02326.x
Subject(s) - raloxifene , pharmacokinetics , confidence interval , medicine , renal function , impaired renal function , urology , creatinine , endocrinology , estrogen receptor , breast cancer , cancer
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.