Bioequivalency Study of Meloxicam Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00601887
First received: January 15, 2008
Last updated: January 31, 2008
Last verified: January 2008
  Purpose

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


Condition Intervention
Inflammation
Drug: Meloxicam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 15 mg Meloxicam Tablets Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: Baseline, Two period, Fourteen day washout ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: March 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601887

Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Soran Hong, MD Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00601887     History of Changes
Other Study ID Numbers: MELO-T15-PVFD-1
Study First Received: January 15, 2008
Last Updated: January 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Roxane Laboratories:
Anti-inflammatory

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014