NCT03362853

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

A Randomized, Single-center, Placebo and Positive Control, 4-period and 4-crossover Clinical Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Malate Capsule on QTc Intervals and Heart Rhythms of Healthy Subjects as Well as the Influence of Food Intake on QTc Intervals and Pharmacokinetic Characteristics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: TaiGen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Nemonoxacin 500Mg Capsule	Receive a single dose in a fasting state
DRUG	Moxifloxacin 400Mg Tablet	Receive a single dose in a fasting state
DRUG	Nemonoxacin 750Mg Capsule	Receive a single dose in a fasting state
DRUG	Placebo oral capsule	Receive a single dose in a fasting state

Timeline

• Start date: 2012-06-25
• Primary completion: 2012-08-10
• Completion: 2012-08-10
• First posted: 2017-12-05
• Last updated: 2017-12-06