Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range

NCT02181322 | Completed Phase 1

• 1 other identifier: 107.243
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax (Maximum measured concentration of the analyte in plasma)

  up to 96 hours after drug administration

• AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 96 hours after drug administration

Secondary Outcomes (8)

• tmax (Time from dosing to the maximum concentration of the analyte in plasma)

  up to 96 hours after drug administration

• AUC0-tf (Total area under the plasma drug concentration-time curve (AUC) from time of administration (0) to the last quantifiable drug concentration)

  up to 96 hours after drug administration

• t½ (Terminal half-life of the analyte in plasma)

  up to 96 hours after drug administration

• Terminal rate constant in plasma

  up to 96 hours after drug administration

• CL/F (Apparent clearance of the analyte in plasma following extravascular administration)

  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, fasted

EXPERIMENTAL

Drug: Meloxicam - high dose

Meloxicam - high dose, fed

EXPERIMENTAL

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%
• In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and 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)
• Disease of the central nervous system (such a epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or 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 one month or less than ten half-lives of the respective drug before enrolment in the study
• Use of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial)
• Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial)
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation (\>= 100 mL within four 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: June 1, 2001
• Primary Completion: September 1, 2001
• Last Updated: July 8, 2014

Record last verified: 2014-07