Abstract：
PURPOSE:Tolvaptan is a selective vasopressin V2 receptor antagonist that can be given orally once daily for treatment of clinically significant hypervolemic and euvolemic hyponatremia (US and Europe) or extracellular volume expansion despite taking other diuretics (Japan). In vitro studies indicated that tolvaptan was a CYP3A4 substrate. METHODS:A single-center, randomized, crossover trial of 60-mg tolvaptan with 240 mL of water or with 240 mL of reconstituted grapefruit juice (washout period of 72 h between doses) was conducted in 20 healthy subjects. Blood samples for tolvaptan plasma concentrations were obtained for 48 h postdose. RESULTS:All subjects completed the trial. Following co-administration with grapefruit juice, tolvaptan concentrations were elevated compared with tolvaptan alone for only 16 h postdose; consequently, the mean elimination half-life of tolvaptan was unchanged, 5.7 vs 5.1 h respectively. The mean maximal plasma concentration (C(max)) and the area under the curve (AUC(∞)) of tolvaptan were increased 1.86- and 1.56-fold respectively when co-administered with grapefruit juice. CONCLUSIONS:It appears that grapefruit juice increases the bioavailability of tolvaptan, but does not affect its systemic elimination. The adverse event profile was consistent with the aquaretic effect of tolvaptan as urinary frequency, thirst, and dry mouth were the most frequently reported events.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Shoaf SE,Mallikaarjun S,Bricmont Pdoi
10.1007/s00228-011-1106-4subject
Has Abstractpub_date
2012-02-01 00:00:00pages
207-11issue
2eissn
0031-6970issn
1432-1041journal_volume
68pub_type
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journal_title：European journal of clinical pharmacology
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journal_title：European journal of clinical pharmacology
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journal_title：European journal of clinical pharmacology
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