Healthy
Conditions
Brief summary
Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality over a dosage range of 7.5 mg to 22.5 mg
Interventions
DRUGMeloxicam - low dose
DRUGMeloxicam - medium dose
DRUGMeloxicam - high dose
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subjects as determined by results of screening * Age range from 21 to 50 years * Broca-Index +- 20% * In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Exclusion criteria
* Any finding of the medical examination (including 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) * Disease of the central nervous system (such a epilepsy) or psychiatric disorders or neurological disorders * History of orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study * Use of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial) * Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial) * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation (\>= 100 mL within four weeks prior to administration or during the trial * Excessive physical activities (within the last week before study) * Anl laboratory value outside the reference range of clinical relevance * History of haemorrhagic diatheses * History of gastrointestinal ulcer, perforation or bleeding * History of bronchial asthma For female subjects: * Pregnancy * Positive pregnancy test * No adequate contraception e.g sterilisation, intrauterine pessary, oral contraceptives * Inability to maintain this adequate contraception during the whole study period * Lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 96 hours after drug administration |
| AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 96 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| CL/F (Apparent clearance of the analyte in plasma following extravascular administration) | up to 96 hours after drug administration |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 96 hours after drug administration |
| AUC0-tf (Total area under the plasma drug concentration-time curve (AUC) from time of administration (0) to the last quantifiable drug concentration) | up to 96 hours after drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 96 hours after drug administration |
| MRTtot (Total mean residence time) | up to 96 hours after drug administration |
| Number of patients with adverse events | up to 10 weeks |
| Vz/F (Apparent volume of distribution of the analyte during the terminal phase) | up to 96 hours after drug administration |
| Terminal rate constant in plasma | up to 96 hours after drug administration |
Outcome results
None listed