Bioequivalency Study of Meloxicam Tablets Under Fasting Conditions - Full Text View

Bioequivalency Study of Meloxicam Tablets Under Fasting Conditions

This study has been completed.

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00618163

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 fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Condition	Intervention
Inflammation	Drug: Meloxicam

ChemIDplus related topics:

Meloxicam

U.S. FDA Resources

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 Fasting Conditions

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:	47
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: NCT00618163

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

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	MELO-T15-PVFS-1
First Received:	January 15, 2008
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00618163
Health Authority:	United States: Institutional Review Board

Keywords provided by Roxane Laboratories:

Anti-inflammatory

Study placed in the following topic categories:

Meloxicam

Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

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 October 17, 2008