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

NCT02183090 | Completed Phase 1

• 1 other identifier: 107.217
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

Study Arms (2)

Meloxicam ampoule

EXPERIMENTAL

Drug: Meloxicam ampoule

Meloxicam tablet

ACTIVE COMPARATOR

Drug: Meloxicam tablet

Interventions

Meloxicam ampoule DRUG

Meloxicam ampoule

Meloxicam tablet DRUG

Meloxicam tablet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Meloxicam

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: November 1, 1998
• Primary Completion: December 1, 1998
• Last Updated: July 8, 2014

Record last verified: 2014-07