NCT00840476

Meloxicam 15 mg Tablets Under Fasting Conditions

A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Meloxicam 15 mg Tablets Versus Mobic® 15 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Meloxicam 15 mg Tablets	1 x 15 mg, single-dose fasting
DRUG	Mobic® 15 mg Tablets	1 x 15 mg, single-dose fasting

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2009-02-10
• Last updated: 2024-08-19
• Results posted: 2009-08-04

Locations

1 site across 1 country: Canada