Clinical trial NCT02183077: Pharmacokinetics and Tolerability of Meloxicam Gel Compared to Meloxicam Tablets in Healthy Subjects
Official title: Pharmacokinetics and Tolerability of 2 x 15 mg Meloxicam (2 x 0.3 g Topical Gel) Over 7 Days Compared to 7.5 mg Meloxicam Tablet (Single Oral Dose) in Healthy Subjects. A Two-way Cross-over, Randomized, Open Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 12
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: Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
* Age \>= 18 and \<= 50 years
* Broca \>= -20% and \<= + 20 %

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* Hypersensitivity to meloxicam and any of the excipients or non-steroidal antirheumatic agents
* Intake of drugs with a long half-life (\>24 hours) (\<= 1 month prior to administration or during the trial)
* 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)
* Smoker (\> 10 cigarettes or \> 3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on study days
* Known alcohol abuse
* Known drug abuse
* Blood donation (\<= 1 months prior to administration)
* Excessive physical activities (\<= 5 days prior to administration)
* History of hemorrhagic diatheses
* History of gastrointestinal ulcer, perforation or bleeding
* History of bronchial asthma
* Any laboratory value outside the normal range of clinical relevance
* History of dermatological diseases
* Skin disease and/or skin lesions at the site of planned application

For female subjects:

* Pregnancy
* Positive pregnancy test
* Breast feeding

Primary outcomes:
measure: Analysis of plasma concentration-time course after topical dose
timeFrame: up to 264 hours after first topical administration
measure: Determination of the ratio AUCss topical/AUC0-∞ oral
timeFrame: up to 96 hours after oral administration
Secondary outcomes:
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 96 hours after oral administration
measure: Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
timeFrame: up to 96 hours after oral administration
measure: Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t)
timeFrame: up to 96 hours after oral administration
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 96 hours after oral administration
measure: Terminal half-life of the analyte in plasma (t½)
timeFrame: up to 96 hours after oral administration
measure: Apparent terminal elimination rate constant
timeFrame: up to 96 hours after oral administration
measure: Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
timeFrame: up to 96 hours after oral administration
measure: Apparent volume of distribution of the analyte during the terminal phase (Vz/F)
timeFrame: up to 96 hours after oral administration
measure: Mean residence time (MRTtot)
timeFrame: up to 96 hours after oral administration
measure: Excretion of metabolites in urine
timeFrame: 0-24 hours after oral administration
measure: Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
timeFrame: up to 264 hours after first topical administration
measure: Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
timeFrame: up to 264 hours after first topical administration
measure: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
timeFrame: up to 264 hours after first topical administration
measure: Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss)
timeFrame: up to 264 hours after first topical administration
measure: Terminal half-life of the analyte in plasma (t½)
timeFrame: up to 264 hours after first topical administration
measure: Apparent terminal elimination rate constant
timeFrame: up to 264 hours after first topical administration
measure: Occurence of adverse events
timeFrame: up to 24 days
measure: Assessment of local and systemic tolerability
timeFrame: up to 24 days
Other outcomes:
Locations:
Study officials:
References: