Official Title: “A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 15 mg Meloxicam Tablets Under Fasting Conditions”

The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: April 2005

Intervention(s) in this Clinical Trial

• Drug: Meloxicam

Primary Measures

• Bioequivalence
  • Time Frame: Baseline, Two period, Fourteen day washout
    Safety Issue?: No

Inclusion Criteria:

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to Meloxicam or any comparable or similar product.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Roxane Laboratories

Overall Clinical Trial Officials and Contacts

Soran Hong, MD Principal Investigator Novum Pharmaceutical Research Services  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618163

Study ID Number: MELO-T15-PVFS-1

ClinicalTrials.gov Identifier: NCT00618163

Health Authority: United States: Institutional Review Board