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

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ClinicalTrials.gov Identifier: NCT02183181
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Meloxicam capsule Drug: Meloxicam tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2008
Actual Primary Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: Meloxicam capsule
Capsules 15 mg
Drug: Meloxicam capsule
Active Comparator: Meloxicam tablet
Tablets 15 mg
Drug: Meloxicam tablet



Primary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma over the time interval zero to infinity (AUC0-infinity) [ Time Frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration ]
  2. Area under the plasma concentration-time curve from 0 h to last concentration time (AUC0-tz) [ Time Frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration ]
  3. Observed maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration ]
  4. Time to reach maximum plasma concentration (Tmax) [ Time Frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration ]
  5. Plasma half-life estimated by (0.693/ kel) ( t ½) [ Time Frame: 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 :
  1. Occurrence of adverse events [ Time Frame: up to 33 days after first administration ]
  2. Drug induced changes in standard laboratory values [ Time Frame: 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 ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183181    
Other Study ID Numbers: 107.274
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action