Healthy
Conditions
Brief summary
Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension.
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% * Written informed consent in accordance with Good Clinical Practice and local legislation
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders * Surgery of the gastro-intestinal tract (except appendectomy) * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * History of orthostatic hypotension, fainting spells and 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 1 month or less than ten half-lives of the respective drug prior to administration * Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during trial) * Participation in another trial with an investigational drug within 2 months prior to administration or during trial * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) * Inability to refrain from smoking on study days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial) * Excessive physical activities (within the last week before the study) * Any laboratory value outside the reference range or 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 |
|---|---|
| Maximum drug plasma concentration (Cmax) | up to 96 hours after drug administration |
| Total area under the plasma concentration-time curve from time to administration to infinity (AUC0-infinity) | up to 96 hours after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum concentration (Tmax) | up to 96 hours after drug administration |
| Total area under the plasma drug concentration-time curve from time of administration to the last quantifiable drug (AUC0-tf) | up to 96 hours after drug administration |
| Apparent terminal elimination rate constant (λz) | up to 96 hours after drug administration |
| Apparent terminal half-life (t1/2) | up to 96 hours after drug administration |
| Mean total residence time (MRTtot) | up to 96 hours after drug administration |
| Total clearance, divided by f (CL/f) | up to 96 hours after drug administration |
| Apparent volume of distribution during the terminal phase, divided by f (Vz/f) | up to 96 hours after drug administration |
| Number of patients with adverse events | up to 67 days |
Outcome results
None listed