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A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China

NCT03235778 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-11-18

No results posted yet for this study

Summary

1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose
2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose

Conditions

  • Healthy

Interventions

DRUG

Felbinac Trometamol Injection

Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump

DRUG

Placebo

Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump

Sponsors & Collaborators

  • Yiling Pharmaceutical Inc.

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, MD · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-17
Primary Completion
2018-03-19
Completion
2018-06-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03235778 on ClinicalTrials.gov