Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5825578 | Clinical Therapeutics | 2014 | 7 Pages |
Abstract
In this study in healthy Korean male volunteers, the test and reference formulations of 160-mg valsartan met the Korean Food and Drug Administration's regulatory criteria for bioequivalence despite the difference in formulation (wet granulation vs dry granulation). Both formulations were well tolerated, with no serious adverse events reported.
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Authors
Ji-Eon MS, Min-Hyo MS, In-Soo PhD, Hyun-Jong PhD, Ree-Sun MS, Geun PhD, Dae-Duk PhD,