Pharmacokinetic and Tolerance Study of Meloxicam Eye Drops in Healthy Volunteers

NCT04322175 | Unknown Phase 1

• 1 other identifier: MLXKDYY
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pharmacokinetics; Tolerance

Outcome Measures

Primary Outcomes (3)

• Concentration of drug prototype-meloxicam in tears of each subject, ng · h / ml

  In a single administration test, tear samples were collected 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after administration, and 8 eyes were taken at each time point.LC-MS

  2 days

• Intraocular pressure examination,mmHg

  In the multiple dose tolerance test, IOP was performed 2 hours (± 20min) after the second dose of Day2.

  1 day

• Corneal fluorescence staining,levels

  Corneal fluorescence staining during the multiple dose tolerance test (Day1-Day3) 1 h after the last daily dose (time window ± 10 min).

  3 days

Study Arms (2)

Single dose pharmacokinetic test

EXPERIMENTAL

The 72 healthy subjects enrolled were admitted to the trial ward the day before the trial. On the day of dosing, the subjects were given 0.1% meloxicam eye drops once, 1 drop / time.

Drug: Meloxicam

Multiple dose tolerance test

EXPERIMENTAL

Eight healthy subjects were enrolled in the trial ward the day before the trial. 0.1% meloxicam eye drops were administered 4 times, 1 drop / time, and were administered at 8:00, 12:00, 16:00 and 20:00 daily for 3 consecutive days.

Drug: Meloxicam

Interventions

Meloxicam DRUG

Meloxicam Eye Drops

Also known as: Mobic

Multiple dose tolerance test; Single dose pharmacokinetic test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily participate in this trial and sign the informed consent before the trial;
• Age: 18 to 45 years old (including 18 and 45 years old) healthy subjects, both male and female;
• Weight and body mass index: female subjects weigh ≥45.0kg and male subjects weigh ≥50.0kg,BMI is in the range of 19 ～ 26 kg / m2 (including 19 and 26);
• Physical examination, vital signs, laboratory examination and ECG examination during the screening period are normal or different Often without clinical significance;
• The corrected visual acuity of both eyes should be ≥1.0. The intraocular pressure, slit lamp, and fundus examination are normal or abnormal. It has no clinical significance. The target eye SchirmerⅠ test result during the screening period is ≥10 mm;
• Subjects were able to communicate well with the researcher and understood and were willing to comply with the requirements of this study.

You may not qualify if:

• Allergic constitution, allergic diseases or known allergies to research drugs / similar drugs;
• Past or current suffering from circulatory system, respiratory system, digestive system, blood system,Menstrual system, immune system, urinary system, endocrine system, and mental illness may be significant Any condition that affects the absorption, distribution, metabolism, and excretion of the drug or affects the safety of the subject;
• People with eye diseases, including history of internal eye surgery or laser surgery;
• Infection screening is abnormal and clinically significant;
• Used any medicine in the last 2 weeks;
• Underwent surgery within 4 weeks prior to the trial, or plan to perform surgery within 2 weeks of the end of the study surgeon;
• Those who need to wear contact lenses during the trial;
• A history of substance abuse, or a positive urine test for substance abuse(Ketamine, morphine, methamphetamine, dimethylene oxyamphetamine, tetrahydrocannabinol);
• Women with a positive blood pregnancy test; women who have not taken effective contraception in the last month,Pregnant and lactating women; women and men of childbearing age who cannot take effective contraception during the trial and within six months after the trial is over;
• Smokers and alcoholics (smokers on average more than 5 cigarettes / day, alcohol consumption on average 2 units / day, 1unit = 10 mL of ethanol, ie 1 unit = 200 mL of beer with 5% alcohol or 25mL of white wine with 40% alcohol or 83mL of wine with 12% alcohol) or a positive breath test, or during the study Stop using any tobacco products and not stop alcohol intake;
• Those who donated more than 200 mL of blood in the 90 days before the test, or lost blood of more than 200 mL for other reasons;
• Participants in any other clinical trials within 90 days before screening;
• Subjects refused to discontinue any use of methyl groups 48 hours before the end of the study until the end of the study xanthine drinks or foods, such as caffeine (coffee, tea, cola, chocolate, etc.), and beverages containing grapefruit;
• Any other condition that the investigator considers inappropriate.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Institution of Drug Clinical Trials

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

Meloxicam

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiuli Zhao, Ph.D.

  Beijing Tongren Hospital, Capital Medical Univsersity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 26, 2020
• Study Start: December 16, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

CN (1)