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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

NCT03362853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-12-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • TaiGen Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03362853 on ClinicalTrials.gov