Clinical trial NCT02183090: Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects
Official title: Pharmacokinetics and Tolerability of a Single 15mg Meloxicam Dose Injected Intramuscularly Compared to a Single Oral 15 mg Meloxicam Tablet 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 investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet


Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by results of screening
* 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 laboratory, blood pressure, pulse rate and electrocardiogram (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)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* Hypersensitivity to meloxicam and/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 month prior to administration)
* Excessive physical activities (≤ 5 days prior to administration)
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma
* For female subjects:

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

Primary outcomes:
measure: AUC0-inf (total area under the plasma drug concentration-time curve)
timeFrame: up to 96 hours after drug administration
measure: Cmax (Maximum drug plasma concentration)
timeFrame: up to 96 hours after drug administration
measure: tmax (Time to achieve Cmax)
timeFrame: up to 96 hours after drug administration
Secondary outcomes:
measure: AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration)
timeFrame: up to 96 hours after drug administration
measure: λz (apparent terminal elimination rate constant)
timeFrame: up to 96 hours after drug administration
measure: t1/2 (apparent terminal elimination half-life)
timeFrame: up to 96 hours after drug administration
measure: MRTtot (Mean residence time)
timeFrame: up to 96 hours after drug administration
measure: CL/f (Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration)
timeFrame: up to 96 hours after drug administration
measure: Vz/f (Apparent volume of distribution during the terminal phase λz following extravascular administration)
timeFrame: up to 96 hours after drug administration
measure: Change from baseline in vital signs (pulse rate, systolic and diastolic blood pressure)
timeFrame: Baseline, days 1-5 of each treatment period
measure: Change from baseline in laboratory parameters
timeFrame: Baseline, days 1-2 and 5 of each treatment period
measure: Number of patients with adverse events
timeFrame: up to 72 hours after day 5 of each treatment period
measure: Tolerability of the intramuscular injection
timeFrame: before and 4 and 24 hours after application of study drug
Other outcomes:
Locations:
Study officials:
References: