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

NCT02183103 | Completed Phase 1

• 1 other identifier: 107.224
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (2)

meloxicam rapid release tablet after an overnight fast

ACTIVE COMPARATOR

Drug: meloxicam rapid release tablet, 12mg, UH AC62MU

meloxicam rapid release tablet after high fat breakfast

EXPERIMENTAL

Drug: meloxicam rapid release tablet, 12mg, UH AC62MU

Interventions

meloxicam rapid release tablet, 12mg, UH AC62MU DRUG

meloxicam rapid release tablet after an overnight fast; meloxicam rapid release tablet after high fat breakfast

Eligibility Criteria

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

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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 4, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 1999
• Primary Completion: May 1, 1999
• Last Updated: July 8, 2014

Record last verified: 2014-07