Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-28 @ 1:15 PM
Study NCT ID:
NCT02170792
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2014-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011899', 'term': 'Ranitidine'}], 'ancestors': [{'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-20', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)', 'timeFrame': 'before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment'}, {'measure': 'Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)', 'timeFrame': 'before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration of drug in plasma ( Cmax )', 'timeFrame': 'before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment'}, {'measure': 'Time from dosing to the maximum concentration of the analyte in plasma (tmax)', 'timeFrame': 'before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment'}, {'measure': 'Changes from baseline in Pulse rate', 'timeFrame': 'baseline up to 36 h after last administration'}, {'measure': 'Changes from baseline in blood pressure (systolic and diastolic)', 'timeFrame': 'baseline up to 36 h after last administration'}, {'measure': 'Changes from baseline in ECG', 'timeFrame': 'baseline up to 36 h after last administration'}, {'measure': 'Changes from baseline in routine laboratory', 'timeFrame': 'baseline up to 36 h after last administration'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'up to 36 h after last administration'}, {'measure': 'Changes in international normalized ratio (INR )', 'timeFrame': 'before and 2 hours after treatment'}, {'measure': 'Changes in activated prothrombin time (aPTT)', 'timeFrame': 'before and 2 hours after treatment'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male subjects as determined by results of screening\n* signed written informed consent in accordance with GCP and local legislation\n* age \\>= 18 and \\<= 50 years\n* Broca \\>= - 20% and \\<0 + 20%\n\nExclusion Criteria:\n\n* any finding of the medical examination (including blood pressure, pulse rate and ECG)\n* history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders\n* history of orthostatic hypotension, fainting spells and blackouts\n* diseases of central nervous system (such as epilepsy) or psychiatric disorders\n* chronic or relevant acute infections\n* History of:\n\n * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n * any bleeding disorder including prolonged or habitual bleeding\n * other hematologic disease\n * cerebral bleeding (e.g. after a car accident)\n * commotio cerebri\n* intake of drugs with a long half-life (\\>24 hours) within 1 month prior to administration\n* use of any drugs which might influence the results of the trial within 10 days prior to administration or during administration\n* participation in another trial with an investigational drug within 2 month prior to administration or during trial\n* smoker (\\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days\n* alcohol abuse (\\>60 g / day)\n* drug abuse\n* blood donation within 1 month prior to administration or during the trial\n* excessive physical activities within 5 days prior to administration or during the trial\n* any laboratory value outside the clinically accepted reference range\n* history of any familial bleeding disorder\n* Thrombocytes \\< 150000 /µl'}, 'identificationModule': {'nctId': 'NCT02170792', 'briefTitle': 'Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial.', 'orgStudyIdInfo': {'id': '1160.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBR 1048 MS with ranitidine', 'description': 'Low, medium or high dose in combination with ranitidine', 'interventionNames': ['Drug: BIBR 1048 MS', 'Drug: Ranitidine']}, {'type': 'EXPERIMENTAL', 'label': 'BIBR 1048 MS without ranitidine', 'description': 'Low, medium or high dose', 'interventionNames': ['Drug: BIBR 1048 MS']}], 'interventions': [{'name': 'BIBR 1048 MS', 'type': 'DRUG', 'description': 'Low, medium or high dose', 'armGroupLabels': ['BIBR 1048 MS with ranitidine', 'BIBR 1048 MS without ranitidine']}, {'name': 'Ranitidine', 'type': 'DRUG', 'otherNames': ['Zantic ®'], 'description': '150mg', 'armGroupLabels': ['BIBR 1048 MS with ranitidine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}