Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects
- Registration Number
- NCT02183090
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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%
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Any findings of the medical examination (including laboratory, blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
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Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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Surgery of the gastro-intestinal tract ( except appendectomy)
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Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
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Chronic or relevant acute infections
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Hypersensitivity to meloxicam and/or non-steroidal antirheumatic agents
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Intake of drugs with a long half-life (>24 hours) (≤ 1 month prior to administration or during the trial)
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Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
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Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
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Smoker (>= 10 cigarettes or >= 3 cigars or >= 3 pipes/day)
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Inability to refrain from smoking on study days
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Known alcohol abuse
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Known drug abuse
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Blood donation (≤ 1 month prior to administration)
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Excessive physical activities (≤ 5 days prior to administration)
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History of hemorrhagic diatheses
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History of gastro-intestinal ulcer, perforation or bleeding
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Meloxicam ampoule Meloxicam ampoule - Meloxicam tablet Meloxicam tablet -
- Primary Outcome Measures
Name Time Method tmax (Time to achieve Cmax) up to 96 hours after drug administration AUC0-inf (total area under the plasma drug concentration-time curve) up to 96 hours after drug administration Cmax (Maximum drug plasma concentration) up to 96 hours after drug administration
- Secondary Outcome Measures
Name Time Method t1/2 (apparent terminal elimination half-life) up to 96 hours after drug administration Change from baseline in laboratory parameters Baseline, days 1-2 and 5 of each treatment period λz (apparent terminal elimination rate constant) up to 96 hours after drug administration Vz/f (Apparent volume of distribution during the terminal phase λz following extravascular administration) up to 96 hours after drug administration Change from baseline in vital signs (pulse rate, systolic and diastolic blood pressure) Baseline, days 1-5 of each treatment period Number of patients with adverse events up to 72 hours after day 5 of each treatment period Tolerability of the intramuscular injection before and 4 and 24 hours after application of study drug AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration) up to 96 hours after drug administration MRTtot (Mean residence time) up to 96 hours after drug administration CL/f (Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration) up to 96 hours after drug administration