Abstract：
:The present study was conducted to determine the absolute bioavailability of fimasartan (FMS; Kanarb(®) ) after the single oral administration of a 60-mg tablet or a single 30-mg intravenous (IV) infusion. This investigation was a randomized, single-dose, open-labeled, two-way crossover study of 16 healthy Korean male subjects. The subjects were divided into two groups (n = 8) and each received either the oral or IV formulation followed by one-week washout period. The Cmax (ng/ml) and AUC∞ (h · ng/ml) following oral and IV administration were 62.4 ± 48.6 and 291.1 ± 121.7; and 683.3 ± 104.3 and 782.3 ± 112.7 (mean ± SD), respectively. The Tmax (h) were 3.0 h (range: 0.5-5.0 h) and 1.0 h (range: 0.8-1.0 h) in the test and reference groups, respectively. The terminal elimination half-lives (t1/2 , h) were similar (5.8 and 5.5 h, respectively) indicating that the route of administration did not influence the absorption or elimination of FMS. The systemic clearance (CL, L/h) and the volume of distribution at steady-state (Vdss , L) were 331.3 ± 444.5 L/h and 403.3 ± 710.4 L following oral administration and 39.1 ± 5.3 L/h and 42.4 ± 25.5 L following IV administration. The absolute bioavailability of the FMS tablet was 18.6%.
journal_name
J Clin Pharmacoljournal_title
Journal of clinical pharmacologyauthors
Ghim JL,Paik SH,Hasanuzzaman M,Chi YH,Choi HK,Kim DH,Shin JGdoi
10.1002/jcph.618subject
Has Abstractpub_date
2016-05-01 00:00:00pages
576-80issue
5eissn
0091-2700issn
1552-4604journal_volume
56pub_type
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