Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU in Healthy Subjects

Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU (Rapid Release Tablet) Given as an Oral Single Dose of 7.5 mg in Healthy Subjects (Two Way, Crossover, Randomized, Open)

Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam rapid releases tablet

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: meloxicam rapid release tablet, 12mg, UH AC62MU

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects as determined by results of screening
• Written informed consent according good clinical practice (GCP) and local legislation
• Age >=18 and <=50 years
• Broca >= -20% and <= +20%

Exclusion Criteria:

• Any finding of the medical examination (blood pressure, pulse rate and electrocardiogram (ECG)) deviating from the normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
• Surgery of gastro-intestinal tract (except appendectomy)
• Disease of central nervous system (such as epilepsy) or psychiatric disorders or neurological disorder
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life ( >24h) (<=1month prior to administration)
• 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)
• Smokers ( >10 cigarettes or >3 cigars or >3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (>60g/day)
• Drug abuse
• Blood donation (<= 1 month prior to administration or during the trial)
• Excessive physical activities (<= 5 days prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance
• History of hemorrhagic diatheses
• History of gastro-intestinal ulcer, perforation or bleeding
• History of bronchial asthma

For female:

• Pregnancy
• Positive pregnancy test
• No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives
• Inability to maintain this adequate contraception during the whole study period
• Lactation period

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: meloxicam rapid release tablet after an overnight fast	Drug: meloxicam rapid release tablet, 12mg, UH AC62MU
Experimental: meloxicam rapid release tablet after high fat breakfast	Drug: meloxicam rapid release tablet, 12mg, UH AC62MU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum measured concentration of the analyte in plasma (Cmax)	predose and up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)	predose and up to 96 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to achieve Cmax (tmax)	predose and up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)	predose and up to 96 hours after drug administration
Terminal rate constant in plasma (λz)	predose and up to 96 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)	predose and up to 96 hours after drug administration
Mean residence time of the analyte total (MRT tot)	predose and up to 96 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)	predose and up to 96 hours after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)	predose and up to 96 hours after drug administration
Number of patients with abnormal changes in laboratory values	Baseline, 96 hours after drug administration
Number of Participants with Adverse Events	Up to day 5 after last drug administration
Number of patients with abnormal changes from baseline in ECG	Baseline, day 5 after last drug administration
Number of patients with abnormal changes from baseline in physical examination	Baseline, day 5 after last drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): May 1, 1999

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 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: 107.224