Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:29 AM
Study NCT ID:
NCT02273492
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2014-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER 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': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of dipyridamole in plasma at steady state (AUCss)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Maximum concentration of dipyridamole in plasma at steady state (Cmax,ss)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte thromboxane B2 (TXB2)', 'timeFrame': 'up to day 19'}, {'measure': 'Maximum concentration of dipyridamole in plasma from 0 to 10h (Cmax,0-10h)', 'timeFrame': 'up to 10 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Area under the concentration-time curve of the analyte in plasma from 0 to 10 h (AUC0-10h)', 'timeFrame': 'Up to 10 hours after start of drug administration'}, {'measure': 'Percent peak trough fluctuation of dipyridamole in plasma (%PTF)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Time to reach the maximum concentration of the analytes in plasma at steady state (Tmax,ss)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Terminal half-life of the analytes in plasma (t1/2)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Percent area under the curve fluctuation of dipyridamole in plasma (AUCfluct)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Area under the concentration-time curve of ASA in plasma at steady state (AUCss)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Maximum concentration of ASA in plasma at steady state (Cmax,ss)', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Change in Inhibition of cyclooxygenase for acetylsalicylic acid (ASA), analyte malondialdehyde', 'timeFrame': 'up to day 19'}, {'measure': 'Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)', 'timeFrame': 'up to day 7'}, {'measure': 'Number of subjects with abnormal changes in laboratory parameters', 'timeFrame': 'Up to 144 hours'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 2 months'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects as determined by results of screening\n* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation\n* Age ≥ 18 and ≤ 55 years\n* Broca ≥ - 20 % and ≤ + 20 %\n\nExclusion Criteria:\n\n* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Surgery of the gastro-intestinal tract (except appendectomy)\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders\n* Chronic or relevant acute infections\n* History of hypersensitivity to Asasantin ER and any of the excipients\n* Intake of drugs with a long half-life (\\> 24 hours) (\\< 1 month prior to administration or during the trial)\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 (\\< 1 month prior to administration or during the trial)\n* Known alcohol abuse\n* Known drug abuse\n* Blood donation (\\< 1 month prior to administration)\n* Excessive physical activities (\\< 5 days prior to administration)\n* History of hemorrhagic diatheses\n* History of gastro-intestinal ulcer, perforating or bleeding\n* History of bronchial asthma\n* Any laboratory value outside the normal range of clinical relevance\n\nFemale subjects:\n\n* Pregnancy\n* Positive pregnancy test\n* No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)\n* Inability to maintain this adequate contraception during the whole study period\n* Lactation period'}, 'identificationModule': {'nctId': 'NCT02273492', 'briefTitle': 'Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin Extended Release (ER) 200/25 mg Capsules b.i.d. in a Randomized, Open, 2-way Cross-over Study in Healthy Subjects', 'orgStudyIdInfo': {'id': '9.136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asasantin ER after a standardized breakfast', 'interventionNames': ['Drug: Asasantin ER', 'Other: Standardized breakfast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Asasantin ER at fasted state', 'interventionNames': ['Drug: Asasantin ER']}], 'interventions': [{'name': 'Asasantin ER', 'type': 'DRUG', 'armGroupLabels': ['Asasantin ER after a standardized breakfast', 'Asasantin ER at fasted state']}, {'name': 'Standardized breakfast', 'type': 'OTHER', 'armGroupLabels': ['Asasantin ER after a standardized breakfast']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}