Pharmacokinetics and safety of single oral doses of amlodipine in patients with and without hepatic impairment: an open study
Darnis, F.; Poupon, R.
International Journal of Clinical Pharmacology Research 13(1): 29-33
1993
ISSN/ISBN: 0251-1649 PMID: 8509234 Document Number: 1115
An open study was conducted to assess the pharmacokinetics, cardiovascular effects and safety of a single oral dose of amlodipine 5 mg in 12 patients with hepatic impairment and eight healthy convalescing subjects. C-max values were found to be similar in both groups although T-max was shorter, and T-12 was longer, in patients with hepatic insufficiency. AUCs were also higher in hepatic patients although these differences were not significantly different. No side-effects or cardiovascular/ECG chnges were observed in either group. Three patients with hepatic failure experienced mild laboratory abnormalities which were of doubtful clinical significance.
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