A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects
Status:
Completed
Trial end date:
2018-05-18
Target enrollment:
Participant gender:
Summary
The purpose of this trial is to compare the pharmacokinetic characteristics of two isosorbide
-5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd and ISMO
Retard (isosorbide -5 -mononitrate extended -release tablet) 40 mg, distributed by RIEMSER
Pharma GmbH.
Primary endpoints are Cmax, AUC(0-t) and AUC(0-inf). Secondary endpoints are Tmax, t1/2 and
λz.