Healthy
Conditions
Brief summary
Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.
Interventions
DRUGMeloxicam gel
DRUGMeloxicam tablet
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 * Signed 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 blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Surgery of the gastrointestinal tract (except appendectomy) * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders * Chronic or relevant acute infections * Hypersensitivity to meloxicam and any of the excipients 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 months prior to administration) * Excessive physical activities (\<= 5 days prior to administration) * History of hemorrhagic diatheses * History of gastrointestinal ulcer, perforation or bleeding * History of bronchial asthma * Any laboratory value outside the normal range of clinical relevance * History of dermatological diseases * Skin disease and/or skin lesions at the site of planned application For female subjects: * Pregnancy * Positive pregnancy test * Breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of plasma concentration-time course after topical dose | up to 264 hours after first topical administration |
| Determination of the ratio AUCss topical/AUC0-∞ oral | up to 96 hours after oral administration |
Secondary
| Measure | Time frame |
|---|---|
| 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) | up to 96 hours after oral administration |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | up to 96 hours after oral administration |
| Terminal half-life of the analyte in plasma (t½) | up to 96 hours after oral administration |
| Apparent terminal elimination rate constant | up to 96 hours after oral administration |
| Apparent clearance of the analyte in plasma following extravascular administration (CL/F) | up to 96 hours after oral administration |
| Apparent volume of distribution of the analyte during the terminal phase (Vz/F) | up to 96 hours after oral administration |
| Mean residence time (MRTtot) | up to 96 hours after oral administration |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 96 hours after oral administration |
| Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) | up to 264 hours after first topical administration |
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) | up to 264 hours after first topical administration |
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) | up to 264 hours after first topical administration |
| Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss) | up to 264 hours after first topical administration |
| Occurence of adverse events | up to 24 days |
| Assessment of local and systemic tolerability | up to 24 days |
| Excretion of metabolites in urine | 0-24 hours after oral administration |
| Time from dosing to the maximum concentration of the analyte in plasma (Tmax) | up to 96 hours after oral administration |
Outcome results
None listed