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

NCT02183181 | Completed Phase 1

• 1 other identifier: 107.274
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

Study Arms (2)

Meloxicam capsule

EXPERIMENTAL

Capsules 15 mg

Drug: Meloxicam capsule

Meloxicam tablet

ACTIVE COMPARATOR

Tablets 15 mg

Drug: Meloxicam tablet

Interventions

Meloxicam capsule DRUG

Meloxicam capsule

Meloxicam tablet DRUG

Meloxicam tablet

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Healthy adult male, aged between 20 and 40 years old
• Body Mass Index (BMI) between 18.5 and 25, inclusive (BMI was calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]).
• Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
• 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.
• No significant deviation from normal hematology including: hemoglobin, hematocrit, white blood count (WBC) with differential, red blood count (RBC) and platelet count
• No significant deviation from normal urinalysis including: pH, occult blood, glucose and protein.

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Meloxicam

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Last Updated: July 8, 2014

Record last verified: 2014-07