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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02183103
Collaborator
(none)
8
Enrollment
2
Arms

Study Details

Study Description

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
  • Drug: meloxicam rapid release tablet, 12mg, UH AC62MU
 Phase 1

Study Design

Study Type:
Interventional
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 :
Apr 1, 1999
Actual Primary Completion Date :
May 1, 1999

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum measured concentration of the analyte in plasma (Cmax) [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) [predose and up to 96 hours after drug administration]

Secondary Outcome Measures

  1. Time to achieve Cmax (tmax) [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) [predose and up to 96 hours after drug administration]

  3. Terminal rate constant in plasma (λz) [predose and up to 96 hours after drug administration]

  4. Terminal half-life of the analyte in plasma (t1/2) [predose and up to 96 hours after drug administration]

  5. Mean residence time of the analyte total (MRT tot) [predose and up to 96 hours after drug administration]

  6. Apparent clearance of the analyte in plasma following extravascular administration (CL/F) [predose and up to 96 hours after drug administration]

  7. Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F) [predose and up to 96 hours after drug administration]

  8. Number of patients with abnormal changes in laboratory values [Baseline, 96 hours after drug administration]

  9. Number of Participants with Adverse Events [Up to day 5 after last drug administration]

  10. Number of patients with abnormal changes from baseline in ECG [Baseline, day 5 after last drug administration]

  11. Number of patients with abnormal changes from baseline in physical examination [Baseline, day 5 after last drug administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02183103
Other Study ID Numbers:
  • 107.224
First Posted:
Jul 8, 2014
Last Update Posted:
Jul 8, 2014
Last Verified:
Jul 1, 2014
Additional relevant MeSH terms:
Meloxicam

Study Results

No Results Posted as of Jul 8, 2014