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Relative Bioavailability of Meloxicam 2 x 7.5 mg Tablets Compared to 15 mg Tablet and Dose Proportionality Over a Dose Range of 7.5 mg and 15 mg in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02276352
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the relative bioavailability of two 7.5 mg meloxicam tablets (American type) compared to one 15 mg meloxicam tablet (American type), and to investigate dose-proportionality over the dosage range 7.5 mg to 15 mg

Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment 1 Drug: Treatment 2 Drug: Treatment 3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Randomized, Three-way Cross-over Study in Healthy Volunteers to Evaluate the Relative Bioavailability of Meloxicam After Single p.o. Administration of 2 x 7.5 mg Meloxicam Tablets Compared to 15 mg Meloxicam Tablet, and Dose-proportionality Over a Dosage Range of 7.5 mg and 15 mg.
Study Start Date : June 1999
Actual Primary Completion Date : August 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: Meloxicam low dose - one tablet Drug: Treatment 1
Experimental: Meloxicam high dose - two tablets Drug: Treatment 2
Active Comparator: Meloxicam high dose - one tablet Drug: Treatment 3



Primary Outcome Measures :
  1. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]
  2. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]

Secondary Outcome Measures :
  1. Time from dosing to the maximum concentration of the analyte in plasma (tmax) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]
  2. Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]
  3. Apparent terminal elimination rate constant (λz ) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]
  4. Terminal half-life of the analyte in plasma (t½) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]
  5. Mean residence time (MRTtot) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]
  6. Apparent clearance of the analyte in plasma following extravascular administration (CL/F) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]
  7. Apparent volume of distribution of the analyte during the terminal phase (Vz/F) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 32, 48, 72 and 96 hours postdose ]
  8. Number of patients with abnormal findings in pulse rate [ Time Frame: predose, up to 96:00 h post dose ]
  9. Number of patients with abnormal findings in systolic and diastolic blood pressure [ Time Frame: predose, up to 96:00 h post dose ]
  10. Number of patients with adverse events [ Time Frame: up to 39 days ]
  11. Number of patients with abnormal changes in laboratory parameters [ Time Frame: predose, up to 96:00 h post dose ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects as determined by results of screening
  • Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • Age >= 18 and <= 50 years
  • Broca >= -20% and <= + 20 %

Exclusion Criteria:

  • Any finding of the medical examination (including laboratory blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastro-intestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Chronic or relevant acute infections
  • Hypersensitivity to meloxicam and/or non-steroidal antirheumatic agents
  • Intake of drugs with a long half-life (>24 hours) (<= 1 month prior to administration or during the trial)
  • Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (<= 2 months prior to administration or during the trial)
  • Smoker (>= 10 cigarettes or >= 3 cigars or >= 3 pipes/day)
  • Inability to refrain from smoking on study days
  • Alcohol abuse
  • Drug abuse
  • Blood donation (<= 1 months prior to administration)
  • Excessive physical activities (<= 5 days prior to administration)
  • History of hemorrhagic diatheses
  • History of gastro-intestinal ulcer, perforation or bleeding
  • History of bronchial asthma

For female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives
  • Inability to maintain this adequate contraception during the whole study period
  • Lactating
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02276352    
Other Study ID Numbers: 107.226
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: May 2014