ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02183103
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: meloxicam rapid release tablet, 12mg, UH AC62MU Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 1999
Actual Primary Completion Date : May 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

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



Primary Outcome Measures :
  1. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: predose and up to 96 hours after drug administration ]
  2. Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity) [ Time Frame: predose and up to 96 hours after drug administration ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183103     History of Changes
Other Study ID Numbers: 107.224
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action