Bioequivalency Study of Meloxicam Tablets Under Fed Conditions

This study has been completed.

First Received: January 15, 2008 Last Updated: January 31, 2008 History of Changes

Sponsor:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00601887

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

Drug Information available for: Meloxicam

U.S. FDA Resources

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

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

Keywords provided by Roxane Laboratories:

Anti-inflammatory

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Meloxicam
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Inflammation
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010