Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Meloxicam, low dose; Drug: Meloxicam, medium dose; Drug: Meloxicam, high dose

• Registration Number: NCT02181309
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2002-04
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-03
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Excessive physical activities (within the last week before the study)
• Any laboratory value outside the reference range or clinical relevance
• History of haemorrhagic diatheses
• History of gastrointestinal ulcer, perforation or bleeding
• History of bronchial asthma

For female subjects:

• Pregnancy
• Positive pregnancy test
• No adequate contraception e.g. sterilisation, intrauterine pessary, oral contraceptives
• Inability to maintain this adequate contraception during the whole study period
• Lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meloxicam low dose, fasted	Meloxicam, low dose	-
Meloxicam medium dose, fasted	Meloxicam, medium dose	-
Meloxicam high dose, fed	Meloxicam, high dose	-
Meloxicam high dose, fasted	Meloxicam, high dose	-

Primary Outcome Measures

Name	Time	Method
Total area under the plasma concentration-time curve from time to administration to infinity (AUC0-infinity)	up to 96 hours after drug administration
Maximum drug plasma concentration (Cmax)	up to 96 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 67 days
Time to maximum concentration (Tmax)	up to 96 hours after drug administration
Total clearance, divided by f (CL/f)	up to 96 hours after drug administration
Apparent volume of distribution during the terminal phase, divided by f (Vz/f)	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
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