Clinical trial NCT02183103: Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU in Healthy Subjects
Official title: Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU (Rapid Release Tablet) Given as an Oral Single Dose of 7.5 mg in Healthy Subjects (Two Way, Crossover, Randomized, Open)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam rapid releases tablet


Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Written informed consent according good clinical practice (GCP) and local legislation
* Age \>=18 and \<=50 years
* Broca \>= -20% and \<= +20%

Exclusion Criteria:

* Any finding of the medical examination (blood pressure, pulse rate and electrocardiogram (ECG)) deviating from the normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
* Surgery of gastro-intestinal tract (except appendectomy)
* Disease of central nervous system (such as epilepsy) or psychiatric disorders or neurological disorder
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life ( \>24h) (\<=1month prior to administration)
* Use of any drugs which might influence the results of the trial (\<=10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
* Smokers ( \>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\>60g/day)
* Drug abuse
* Blood donation (\<= 1 month prior to administration or during the trial)
* Excessive physical activities (\<= 5 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma

For female:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives
* Inability to maintain this adequate contraception during the whole study period
* Lactation period

Primary outcomes:
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: predose and up to 96 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)
timeFrame: predose and up to 96 hours after drug administration
Secondary outcomes:
measure: Time to achieve Cmax (tmax)
timeFrame: predose and up to 96 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)
timeFrame: predose and up to 96 hours after drug administration
measure: Terminal rate constant in plasma (λz)
timeFrame: predose and up to 96 hours after drug administration
measure: Terminal half-life of the analyte in plasma (t1/2)
timeFrame: predose and up to 96 hours after drug administration
measure: Mean residence time of the analyte total (MRT tot)
timeFrame: predose and up to 96 hours after drug administration
measure: Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
timeFrame: predose and up to 96 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
timeFrame: predose and up to 96 hours after drug administration
measure: Number of patients with abnormal changes in laboratory values
timeFrame: Baseline, 96 hours after drug administration
measure: Number of Participants with Adverse Events
timeFrame: Up to day 5 after last drug administration
measure: Number of patients with abnormal changes from baseline in ECG
timeFrame: Baseline, day 5 after last drug administration
measure: Number of patients with abnormal changes from baseline in physical examination
timeFrame: Baseline, day 5 after last drug administration
Other outcomes:
Locations:
Study officials:
References: