Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers

NCT02181309 | Completed Phase 1

• 1 other identifier: 107.254
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum drug plasma concentration (Cmax)

  up to 96 hours after drug administration

• Total area under the plasma concentration-time curve from time to administration to infinity (AUC0-infinity)

  up to 96 hours after drug administration

Secondary Outcomes (8)

• Time to maximum concentration (Tmax)

  up to 96 hours after drug administration

• Total area under the plasma drug concentration-time curve from time of administration to the last quantifiable drug (AUC0-tf)

  up to 96 hours after drug administration

• Apparent terminal elimination rate constant (λz)

  up to 96 hours after drug administration

• Apparent terminal half-life (t1/2)

  up to 96 hours after drug administration

• Mean total residence time (MRTtot)

  up to 96 hours after drug administration

Study Arms (4)

Meloxicam low dose, fasted

EXPERIMENTAL

Drug: Meloxicam, low dose

Meloxicam medium dose, fasted

EXPERIMENTAL

Drug: Meloxicam, medium dose

Meloxicam high dose, fed

EXPERIMENTAL

Drug: Meloxicam, high dose

Meloxicam high dose, fasted

ACTIVE COMPARATOR

Drug: Meloxicam, high dose

Interventions

Meloxicam, low dose DRUG

Meloxicam low dose, fasted

Meloxicam, medium dose DRUG

Meloxicam medium dose, fasted

Meloxicam, high dose DRUG

Meloxicam high dose, fasted; Meloxicam high dose, fed

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects as determined by results of screening
• Age range from 21 to 50 years
• Broca index +/- 20%
• Written informed consent in accordance with Good Clinical Practice and local legislation

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• Surgery of the gastro-intestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells and blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than ten half-lives of the respective drug prior to administration
• Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during trial)
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on study days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)

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 2, 2014
• First Posted: July 3, 2014
• Study Start: January 1, 2002
• Primary Completion: April 1, 2002
• Last Updated: July 8, 2014

Record last verified: 2014-07