Special Population Subjects with Hepatic Impairment

Note the apparent relative total clearance was calculated as CLtot/F = dose/AUC(o-5h). 

The predicted changes, which are within the conventional equivalence bounds, are too small to suggest any meaningful clinical consequences. 

In conclusion, the rapid acting insulin, HMR1964 (insulin glulisine) maintains its pharmacokinetic properties in subjects with decreased renal function covering a wide range of renal impairment. 

As a consequence, no dose adjustments in patients with renal failure are warranted on the basis of intrinsic properties of HMR1964 (insulin glulisine). 

PURPOSE AND RATIONALE A pharmacokinetic study in individuals with impaired hepatic function is recommended when hepatic impairment is likely significantly to alter the pharmacokinetics of a drug or its metabolite(s) such that a dose adjustment may be required. 

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II.S.ll Special Population Subjects with Hepatic Impairment 693... 

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