Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects

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 to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg meloxicam injection in comparison to the 15 mg oral tablet

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Meloxicam ampoule; Drug: Meloxicam tablet

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Meloxicam tablet	Drug: Meloxicam tablet
EXPERIMENTAL: Meloxicam ampoule	Drug: Meloxicam ampoule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-inf (total area under the plasma drug concentration-time curve)	up to 96 hours after drug administration
Cmax (Maximum drug plasma concentration)	up to 96 hours after drug administration
tmax (Time to achieve Cmax)	up to 96 hours after drug administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 1998
• Primary Completion (ACTUAL): December 1, 1998

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (ESTIMATE): July 8, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: 107.217