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Pharmacokinetic and Tolerance Study of Meloxicam Eye Drops in Healthy Volunteers

NCT04322175 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-04-28

No results posted yet for this study

Summary

The pharmacokinetics, safety, and tolerability of meloxicam eye drops in Chinese healthy volunteers were evaluated to provide a basis for the formulation of a phase II clinical trial dosing regimen for this product. Including pre-tests and formal trials, formal trials include single-dose pharmacokinetics tests and multiple-dose tolerance tests (4 times a day for 3 consecutive days).

Conditions

  • Healthy Volunteers

Interventions

DRUG

Meloxicam

Meloxicam Eye Drops

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Xiuli Zhao, Ph.D. · Beijing Tongren Hospital, Capital Medical Univsersity

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2020-06-01
Completion
2020-07-01

Countries

  • China

Study Locations

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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 NCT04322175 on ClinicalTrials.gov