Bioequivalence Study of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) in Healthy Adult Volunteers

A Randomized, Single-dose, Two-way Crossover Study to Assess the Bioequivalence of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) Administered to Healthy Adult Volunteers

Primary Objective:

To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg (Reference, R) following oral administration.

Secondary Objective:

To investigate the safety and tolerability of meloxicam following a single dose of meloxicam capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Meloxicam tablet; Drug: Meloxicam capsule

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study
2. Healthy adult male, aged between 20 and 40 years old
3. Body Mass Index (BMI) between 18.5 and 25, inclusive (BMI was calculated as weight in kilogram [kg]/height in meters2 [m2]).
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from biochemistry including: aspartate transaminase (SGOT/AST), alanine transaminase (SGPT/ALT), gamma-glutamyl-transferase (GGT), alkaline phosphatase, total bilirubin, albumin, glucose, blood urea nitrogen (BUN), creatinine, uric acid, total cholesterol and triglyceride.
6. No significant deviation from normal hematology including: hemoglobin, hematocrit, white blood count (WBC) with differential, red blood count (RBC) and platelet count
7. No significant deviation from normal urinalysis including: pH, occult blood, glucose and protein.

Exclusion Criteria:

1. History of drug or alcohol abuse within the past one year
2. Medical history of allergic asthma or sensitivity to analogous drug
3. Evidence of chronic or acute infectious diseases from 4 weeks before the study
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation
6. Planned vaccination during the time course of the study.
7. Taking any clinical investigation drug from 3 months before the study
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study
9. Blood donation of more than 500 ml within the past 3 months
10. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
11. A positive test for HIV antibody

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meloxicam capsule; Capsules 15 mg	Drug: Meloxicam capsule
Active Comparator: Meloxicam tablet; Tablets 15 mg	Drug: Meloxicam tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval zero to infinity (AUC0-infinity)	0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
Area under the plasma concentration-time curve from 0 h to last concentration time (AUC0-tz)	0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
Observed maximum measured concentration of the analyte in plasma (Cmax)	0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
Time to reach maximum plasma concentration (Tmax)	0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration
Plasma half-life estimated by (0.693/ kel) ( t ½)	0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events	up to 33 days after first administration
Drug induced changes in standard laboratory values	screening phase (at least 10hours fasting), before and 24 h following drug administration on each study day, within 14 days after completion of all two periods

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: 107.274