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A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects

NCT03922373 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-19

No results posted yet for this study

Summary

Objective to study the pharmacokinetic, safety and efficacy of Single-dose and multiple-dose of benzonatate in Chinese healthy male and female subjects.

Conditions

Interventions

DRUG

Group A: Benzonatate 100mg

Subjects in group A will be given benzonatate 100mg once after a 10-hour fast in the first day of the trail

DRUG

Group B: Benzonatate 200mg

Subjects in group B will be given benzonatate 200mg once after a 10-hour fast in the first day of the trail, and they will be given benzonatate 200mg thrice in the second and third day of the trail, in the fourth day, they will be given benzonatate 200mg once after a 10-hour fast.

DRUG

Group C: Benzonatate 400mg

Subjects in group C will be given benzonatate 400mg once after a 10-hour fast in the first day of the trail

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yang Lin, M.D. · Beijing Anzhen Hospital

  • Shan Jing, M.D. · Beijing Anzhen Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2019-02-27
Completion
2019-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03922373 on ClinicalTrials.gov