A Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Capsule on QTc Intervals and Heart Rhythms of Healthy Subjects and the Influence of Food Intake on QTc Intervals and Pharmacokinetic Characteristics

Phase 1 Completed 48 enrolled TaiGen Biotechnology Co., Ltd.

RandomizedCrossoverQuadruple-blindTreatment

Summary

A randomized, single-center, placebo and positive control, 4-period and 4-crossover clinical study with the following main purposes: (1) To evaluate the effect of a single-dose oral administration of nemonoxacin malate capsule on QTc intervals and heart rhythms of healthy subjects. (2) To evaluate the influence of food intake on QTc intervals and pharmacokinetic characteristics.

Timeline

Start: 2012-06-25
Primary completion: 2012-08-10
Completion: 2012-08-10

Publications

Zhao C, Lv Y, Li X, Hou F, Ma X, Wei M, Kang Z, Cui L, Xia Y, Liu Y, Tian J. Effects of Nemonoxacin on Thorough ECG QT/QTc Interval: A Randomized, Placebo- and Positive-controlled Crossover Study in Healthy Chinese Adults. Clin Ther. 2018 Jun;40(6):983-992. doi: 10.1016/j.clinthera.2018.04.014. Epub 2018 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Moxifloxacin	Small molecule	400 mg	Oral
Subject	Nemonoxacin	Small molecule	500 mg	Oral
Subject	Nemonoxacin	Small molecule	750 mg	Oral

Indications

No indication recorded.