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

NCT03617510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-07-02

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
3. To provide the basis for the dose for the follow-up clinical study.

Conditions

Interventions

DRUG

Felbinac Trometamol Injection

Felbinac Trometamol Injection will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the drug was given 7 times,3 times/day,once every 8 hours. It means the drug was given 3 times on D3 and D4,once on D5.

DRUG

Placebos

Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.

Sponsors & Collaborators

  • Shijiazhuang Yiling Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, Doctor · 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
2018-07-10
Primary Completion
2018-11-05
Completion
2019-04-30

Countries

  • China

Study Locations

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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 NCT03617510 on ClinicalTrials.gov