Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT02182960
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2014-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Ibuprofen Enantiomers Compared With Standard Brufen Sirup in Healthy Male Volunteers
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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'lastUpdateSubmitDate': '2018-08-29', 'studyFirstSubmitDate': '2014-07-04', 'studyFirstSubmitQcDate': '2014-07-04', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)', 'timeFrame': 'Up to 12 hours after each administration'}, {'measure': 'Maximum drug plasma concentration (Cmax)', 'timeFrame': 'Up to 12 hours after each administration'}], 'secondaryOutcomes': [{'measure': 'Time to reach the maximum concentration of the analyte in plasma (tmax)', 'timeFrame': 'Up to 12 hours after each administration'}, {'measure': 'Apparent terminal rate constant (λz)', 'timeFrame': 'Up to 12 hours after each administration'}, {'measure': 'Apparent terminal half-life of the analyte in plasma (t1/2)', 'timeFrame': 'Up to 12 hours after each administration'}, {'measure': 'Total area under the plasma drug concentration-time curve from time zero to the last quantifiable drug (AUC0-t(last))', 'timeFrame': 'Up to 12 hours after each administration'}, {'measure': 'Mean residence time, total (MRTtot)', 'timeFrame': 'Up to 12 hours after each administration'}, {'measure': 'Total plasma clearance divided by the systemic availability factor (CL/f)', 'timeFrame': 'Up to 12 hours after each administration'}, {'measure': 'Volume of distribution during the terminal phase λz, divided by f (Vz/f)', 'timeFrame': 'Up to 12 hours after each administration'}, {'measure': 'Number of adverse events', 'timeFrame': 'Up to 8 days after last drug administration'}, {'measure': 'Change from baseline in 12-lead ECG (electrocardiogram)', 'timeFrame': 'Baseline, 8 days after last drug administration'}, {'measure': 'Change in vital functions (blood pressure and puls rate)', 'timeFrame': 'Baseline, up to 8 days after last drug administration'}, {'measure': 'Change from baseline in standard laboratory evaluation', 'timeFrame': 'Baseline, 8 days after last drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Pharmacokinetics (relative bioavailability), safety and tolerability'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males from 21 to 50 years and within +-20% of their normal weight (Broca index)\n* Written informed consent\n\nExclusion Criteria:\n\n* Any findings of the medical examination or laboratory tests deviating from normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory (especially bronchial asthma and chronic obstructive pulmonary disease), cardiovascular, metabolic, immunological or hormonal disorders\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders\n* History of orthostatic hypotension, fainting spells or blackouts\n* Chronic or relevant acute infections\n* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n* Intake of a drug with a long half-life (\\>=24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study\n* Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial\n* Participation in another trial with an investigational drug within two months prior to the start of the study\n* Smoker (\\> 10 cigarettes or 3 cigars or 3 pipes/day)\n* Inability to refrain from smoking on study days\n* Alcohol abuse\n* Drug abuse\n* Blood donation (\\>100 ml) within four weeks prior to administration\n* Other disease or abnormality of clinical relevance\n* Excessive physical activities within two weeks prior to administration or during the trial'}, 'identificationModule': {'nctId': 'NCT02182960', 'briefTitle': 'Bioavailability of Ibuprofen Enantiomers Compared With Standard Brufen Sirup in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Two Way Cross Over Study to Relative Bioavailability of Ibuprofen Enantiomers After Single p.o. Administration of 200 mg Syrup (T) Compared With 200 mg Standard Brufen Sirup (R)', 'orgStudyIdInfo': {'id': '1024.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen', 'interventionNames': ['Drug: Ibuprofen syrup']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brufen', 'interventionNames': ['Drug: Brufen syrup']}], 'interventions': [{'name': 'Ibuprofen syrup', 'type': 'DRUG', 'armGroupLabels': ['Ibuprofen']}, {'name': 'Brufen syrup', 'type': 'DRUG', 'armGroupLabels': ['Brufen']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}