CompletedPhase 1ACTRN12609000474257

Study of the uptake into, and removal from the human body, of meloxicam when taken in two different forms of the medication: a new formulation of meloxicam, Meloxicam Nanoformulation capsules; and marketed capsules (known as Mobic (Registered trademark(R)), when taken after a fast and after a high fat breakfast.

Single-Dose, four-way crossover, relative bioavailability study of Meloxicam Nanoformulation 7.5 mg Capsules and Mobic (Registered Trademark (R)) 7.5 mg Capsules in Healthy subjects under Fed and Fasted Condition

Sponsor

iCeutica Pty Ltd

Enrollment

14 participants

Start Date

Jul 20, 2009

Study Type

Interventional

Conditions

Inflammation

Summary

The study will examine the uptake into, and removal from the human body, of meloxicam. The update and removal of meloxicam from the Meloxicam Nanoformulation capsules and marketed capsules (called Mobic (R)) will be compared, when they are taken after a fast and after a high fat breakfast. There will be four treatments in the study. The Sponsor wants to know if the meloxicam in the Meloxicam Nanoformulation capsules is absorbed more quickly than the meloxicam in Mobic(R).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares how a new nano-formulation of the pain reliever meloxicam is absorbed by the body compared to the standard marketed version. It is for healthy adults aged 18 to 55 and tests absorption both on an empty stomach and after a high-fat meal.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arm 1: Meloxicam Nanoformulation, 7.5 mg Capsule, single dose, oral, taken after minimum 10 hr fast Arm 2: Mobic 7.5 mg Capsule, single dose, oral, taken after minimum 10 hr fast Arm 3: Meloxicam

Arm 1: Meloxicam Nanoformulation, 7.5 mg Capsule, single dose, oral, taken after minimum 10 hr fast Arm 2: Mobic 7.5 mg Capsule, single dose, oral, taken after minimum 10 hr fast Arm 3: Meloxicam Nanoformulation, 7.5 mg Capsule, single dose, oral, taken 30 mins after high fat breakfast Arm 4: Mobic 7.5 mg Capsule, single dose, oral, taken 30 mins after high fat breakfast Washout period between treatment arms is 7 days. Each subject will undergo all 4 treatment arms.