Healthy
Conditions
Brief summary
Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| tmax (Time to achieve Cmax) | up to 96 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Vz/f (Apparent volume of distribution during the terminal phase λz following extravascular administration) | up to 96 hours after drug administration |
| 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 |
| Change from baseline in laboratory parameters | Baseline, days 1-2 and 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 |
| Change from baseline in vital signs (pulse rate, systolic and diastolic blood pressure) | Baseline, days 1-5 of each treatment period |
| λz (apparent terminal elimination rate constant) | up to 96 hours after drug administration |
| t1/2 (apparent terminal elimination half-life) | up to 96 hours after drug administration |
Outcome results
None listed