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Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02183090
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Tolerability of a Single 15mg Meloxicam Dose Injected Intramuscularly Compared to a Single Oral 15 mg Meloxicam Tablet in Healthy Subjects. A Two-way Cross-over, Randomized, Open Study.
Study Start Date : November 1998
Actual Primary Completion Date : December 1998

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: Meloxicam ampoule Drug: Meloxicam ampoule
Active Comparator: Meloxicam tablet Drug: Meloxicam tablet



Primary Outcome Measures :
  1. AUC0-inf (total area under the plasma drug concentration-time curve) [ Time Frame: up to 96 hours after drug administration ]
  2. Cmax (Maximum drug plasma concentration) [ Time Frame: up to 96 hours after drug administration ]
  3. tmax (Time to achieve Cmax) [ Time Frame: up to 96 hours after drug administration ]

Secondary Outcome Measures :
  1. AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration) [ Time Frame: up to 96 hours after drug administration ]
  2. λz (apparent terminal elimination rate constant) [ Time Frame: up to 96 hours after drug administration ]
  3. t1/2 (apparent terminal elimination half-life) [ Time Frame: up to 96 hours after drug administration ]
  4. MRTtot (Mean residence time) [ Time Frame: up to 96 hours after drug administration ]
  5. CL/f (Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration) [ Time Frame: up to 96 hours after drug administration ]
  6. Vz/f (Apparent volume of distribution during the terminal phase λz following extravascular administration) [ Time Frame: up to 96 hours after drug administration ]
  7. Change from baseline in vital signs (pulse rate, systolic and diastolic blood pressure) [ Time Frame: Baseline, days 1-5 of each treatment period ]
  8. Change from baseline in laboratory parameters [ Time Frame: Baseline, days 1-2 and 5 of each treatment period ]
  9. Number of patients with adverse events [ Time Frame: up to 72 hours after day 5 of each treatment period ]
  10. Tolerability of the intramuscular injection [ Time Frame: before and 4 and 24 hours after application of study drug ]


Information from the National Library of Medicine

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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 and local legislation
  • Age ≥ 18 and ≤ 50 years
  • Broca > - 20% and < + 20%

Exclusion Criteria:

  • Any findings of the medical examination (including laboratory, blood pressure, pulse rate and electrocardiogram (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
  • Known alcohol abuse
  • Known drug abuse
  • Blood donation (≤ 1 month 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, IUD (intrauterine device), oral contraceptives
    • Inability to maintain this adequate contraception during the whole study period
    • Lactation period

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183090    
Other Study ID Numbers: 107.217
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