Healthy Volunteers Clinical Trial
Official title:
Pharmacokinetics and Tolerance of Meloxicam Eye Drops in Healthy Volunteers, a Phase I , Single-dose and Multiple-dose, Open-labeled Clinical Trial
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).
Meloxicam eye drops is a new class 2 drug of the country. The main ingredients are meloxicam.
The other ingredients are hydroxypropyl-β-cyclodextrin, sodium hydroxide, boric acid, sodium
chloride and water for injection. Among them, hydroxypropyl-β-cyclodextrin can increase the
solubility of meloxicam and improve the stability of the solution. The indication of
meloxicam eye drops is non-infectious ocular inflammation, especially for inflammation and
complications after cataract surgery. The possible adverse reaction is transient tingling in
the eye after eye drops.
Meloxicam is a non-steroidal anti-inflammatory drug (NSAIDS) that selectively inhibits COX-2
cyclooxygenase. It is currently widely used in the treatment of acute and chronic
inflammation and pain, and its mechanism of action is to prevent the production of
prostaglandins (PGs) that cause inflammation by inhibiting cyclooxygenase (COX).
Non-infectious ocular inflammation is usually caused by the synthesis and release of
inflammatory mediators such as prostaglandin (PG) after eye tissues are stimulated. Because
non-steroidal anti-inflammatory drugs have anti-inflammatory, anti-allergic and analgesic
effects, and have no adverse effects of glucocorticoids, their application in ophthalmology
has been valued.
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