Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Meloxicam, low doseDrug: Meloxicam, medium doseDrug: Meloxicam, high dose
- Registration Number
- NCT02181309
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Meloxicam low dose, fasted Meloxicam, low dose - Meloxicam medium dose, fasted Meloxicam, medium dose - Meloxicam high dose, fed Meloxicam, high dose - Meloxicam high dose, fasted Meloxicam, high dose -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time to maximum concentration (Tmax) 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 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 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 Number of patients with adverse events up to 67 days