Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-24 @ 5:57 PM
Study NCT ID:
NCT02183103
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum measured concentration of the analyte in plasma (Cmax)', 'timeFrame': 'predose and up to 96 hours after drug administration'}, {'measure': 'Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC 0-infinity)', 'timeFrame': 'predose and up to 96 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'Time to achieve Cmax (tmax)', 'timeFrame': 'predose and up to 96 hours after drug administration'}, {'measure': 'Area under the concentration-time curve of the analyte in plasma from time zero to t (AUC 0-t)', 'timeFrame': 'predose and up to 96 hours after drug administration'}, {'measure': 'Terminal rate constant in plasma (λz)', 'timeFrame': 'predose and up to 96 hours after drug administration'}, {'measure': 'Terminal half-life of the analyte in plasma (t1/2)', 'timeFrame': 'predose and up to 96 hours after drug administration'}, {'measure': 'Mean residence time of the analyte total (MRT tot)', 'timeFrame': 'predose and up to 96 hours after drug administration'}, {'measure': 'Apparent clearance of the analyte in plasma following extravascular administration (CL/F)', 'timeFrame': 'predose and up to 96 hours after drug administration'}, {'measure': 'Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)', 'timeFrame': 'predose and up to 96 hours after drug administration'}, {'measure': 'Number of patients with abnormal changes in laboratory values', 'timeFrame': 'Baseline, 96 hours after drug administration'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'Up to day 5 after last drug administration'}, {'measure': 'Number of patients with abnormal changes from baseline in ECG', 'timeFrame': 'Baseline, day 5 after last drug administration'}, {'measure': 'Number of patients with abnormal changes from baseline in physical examination', 'timeFrame': 'Baseline, day 5 after last drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam rapid releases tablet'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects as determined by results of screening\n* Written informed consent according good clinical practice (GCP) and local legislation\n* Age \\>=18 and \\<=50 years\n* Broca \\>= -20% and \\<= +20%\n\nExclusion Criteria:\n\n* Any finding of the medical examination (blood pressure, pulse rate and electrocardiogram (ECG)) deviating from the normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder\n* Surgery of gastro-intestinal tract (except appendectomy)\n* Disease of central nervous system (such as epilepsy) or psychiatric disorders or neurological disorder\n* History of orthostatic hypotension, fainting spells or blackouts\n* Chronic or relevant acute infections\n* History of allergy/hypersensitivity (including drug allergy) which deemed relevant to the trial as judged by the investigator\n* Intake of drugs with a long half-life ( \\>24h) (\\<=1month prior to administration)\n* Use of any drugs which might influence the results of the trial (\\<=10 days prior to administration or during the trial)\n* Participation in another trial with an investigational drug (\\<= 2 months prior to administration or during the trial)\n* Smokers ( \\>10 cigarettes or \\>3 cigars or \\>3 pipes/day)\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (\\>60g/day)\n* Drug abuse\n* Blood donation (\\<= 1 month prior to administration or during the trial)\n* Excessive physical activities (\\<= 5 days prior to administration or during the trial)\n* Any laboratory value outside the reference range of clinical relevance\n* History of hemorrhagic diatheses\n* History of gastro-intestinal ulcer, perforation or bleeding\n* History of bronchial asthma\n\nFor female:\n\n* Pregnancy\n* Positive pregnancy test\n* No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives\n* Inability to maintain this adequate contraception during the whole study period\n* Lactation period'}, 'identificationModule': {'nctId': 'NCT02183103', 'briefTitle': 'Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '107.224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'meloxicam rapid release tablet after an overnight fast', 'interventionNames': ['Drug: meloxicam rapid release tablet, 12mg, UH AC62MU']}, {'type': 'EXPERIMENTAL', 'label': 'meloxicam rapid release tablet after high fat breakfast', 'interventionNames': ['Drug: meloxicam rapid release tablet, 12mg, UH AC62MU']}], 'interventions': [{'name': 'meloxicam rapid release tablet, 12mg, UH AC62MU', 'type': 'DRUG', 'armGroupLabels': ['meloxicam rapid release tablet after an overnight fast', 'meloxicam rapid release tablet after high fat breakfast']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}