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

Phase 1
Completed
Conditions
Healthy
Interventions
Registration Number
NCT02183103
Lead Sponsor
Boehringer Ingelheim
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
8
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
meloxicam rapid release tablet after an overnight fastmeloxicam rapid release tablet, 12mg, UH AC62MU-
meloxicam rapid release tablet after high fat breakfastmeloxicam rapid release tablet, 12mg, UH AC62MU-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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
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 valuesBaseline, 96 hours after drug administration
Mean residence time of the analyte total (MRT tot)predose and up to 96 hours after drug administration
Number of Participants with Adverse EventsUp to day 5 after last drug administration
Number of patients with abnormal changes from baseline in physical examinationBaseline, day 5 after last drug administration
Time to achieve Cmax (tmax)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
Terminal half-life of the analyte in plasma (t1/2)predose and up to 96 hours after drug administration
Number of patients with abnormal changes from baseline in ECGBaseline, day 5 after last drug administration
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