Clinical trial NCT02181309: Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers
Official title: An Open, Randomised, Four-way Crossover Study in Healthy Volunteers to Evaluate the Effect of Food on the Pharmacokinetics of Meloxicam After a Single p.o. Administration of 22.5 mg Meloxicam Oral Suspension and Dose-proportionality Over a Dosage Range of 7.5 mg to 22.5 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-03
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum drug plasma concentration (Cmax)
timeFrame: up to 96 hours after drug administration
measure: Total area under the plasma concentration-time curve from time to administration to infinity (AUC0-infinity)
timeFrame: up to 96 hours after drug administration
Secondary outcomes:
measure: Time to maximum concentration (Tmax)
timeFrame: up to 96 hours after drug administration
measure: Total area under the plasma drug concentration-time curve from time of administration to the last quantifiable drug (AUC0-tf)
timeFrame: up to 96 hours after drug administration
measure: Apparent terminal elimination rate constant (λz)
timeFrame: up to 96 hours after drug administration
measure: Apparent terminal half-life (t1/2)
timeFrame: up to 96 hours after drug administration
measure: Mean total residence time (MRTtot)
timeFrame: up to 96 hours after drug administration
measure: Total clearance, divided by f (CL/f)
timeFrame: up to 96 hours after drug administration
measure: Apparent volume of distribution during the terminal phase, divided by f (Vz/f)
timeFrame: up to 96 hours after drug administration
measure: Number of patients with adverse events
timeFrame: up to 67 days
Other outcomes:
Locations:
Study officials:
References: