Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02181322
- Lead Sponsor
- Boehringer Ingelheim
- 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
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Meloxicam - medium dose, fasted Meloxicam - medium dose - Meloxicam - high dose, fasted Meloxicam - high dose - Meloxicam - high dose, fed Meloxicam - high dose - Meloxicam - low dose, fasted Meloxicam - low dose -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 CL/F (Apparent clearance of the analyte in plasma following extravascular administration) up to 96 hours after drug administration Vz/F (Apparent volume of distribution of the analyte during the terminal phase) 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 Terminal rate constant in plasma up to 96 hours after drug administration