Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers

An Open, Randomised, Four-way Crossover Study in Healthy Volunteers to Evaluate the Effect of Food on the Pharmacokinetics of Meloxicam After a Single p.o. Administration of 22.5 mg Meloxicam Oral Suspension and Dose-proportionality Over a Dosage Range of 7.5 mg to 22.5 mg

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Meloxicam, low dose; Drug: Meloxicam, medium dose; Drug: Meloxicam, high dose

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meloxicam low dose, fasted	Drug: Meloxicam, low dose
Experimental: Meloxicam medium dose, fasted	Drug: Meloxicam, medium dose
Experimental: Meloxicam high dose, fed	Drug: Meloxicam, high dose
Active Comparator: Meloxicam high dose, fasted	Drug: Meloxicam, high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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
Number of patients with adverse events	up to 67 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): April 1, 2002

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 3, 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: 107.254