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Entecavir pharmacokinetics, safety, and tolerability after multiple ascending doses in healthy subjects.

A double-blind, placebo-controlled, multiple oral dose escalation study was conducted to investigate the pharmacokinetics, safety, and tolerability of entecavir in healthy subjects. Eight subjects were assigned to each of the 3 dose panels (0.1 mg, 0.5 mg, and 1 mg or matched placebo once daily for 14 days). Blood and urine samples were collected for pharmacokinetic analyses. Entecavir was rapidly absorbed, with peak plasma concentration occurring within 1 hour of dosing. Steady-state plasma concentrations of entecavir were achieved by 10 days following the initial dose. At steady state, the mean area under the plasma concentration-time curve over 1 dosing interval, increased approximately proportional to dose. Entecavir had a mean terminal half-life ranging from 128 to 149 hours and an effective half-life of approximately 24 hours. Elimination was predominantly through renal excretion, with mean urinary recovery ranging from 62% to 73%. Entecavir was safe and well tolerated when administered at doses ranging from 0.1 mg to 1 mg/d for 14 days.[1]

References

  1. Entecavir pharmacokinetics, safety, and tolerability after multiple ascending doses in healthy subjects. Yan, J.H., Bifano, M., Olsen, S., Smith, R.A., Zhang, D., Grasela, D.M., Lacreta, F. Journal of clinical pharmacology. (2006) [Pubmed]
 
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