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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000474257

Enrollment

Registered

2009-06-17

Start date

2009-07-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Available for entire study period. Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 and weighing at least 50 kg. In good general health.

Exclusion criteria

History of hypersensitivity to naproxen, aspirin or related compounds. History of gastrointestinal ulcers or bleeding. History of surgery of the digestive tract (except for appendectomy). Presence of any conditions that affect the absorption, metabolism or passage of drugs out of the body (e.g. sprue, coeliac disease, Crohn's disease, colitis, liver or kidney conditions). Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism. Use of any drugs known to induce of inhibit hepatic drug metabolism within 30 days of planned dosing. If femals, lactating, or positive pregnancy test at screening, or prior to each of the treatment periods.

Outcome results