Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-01 @ 9:01 PM
Study NCT ID:
NCT02273505
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) and in a Combination of Persantin Immediate Release Tablets and ASA Tablets in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068342', 'term': 'Aspirin, Dipyridamole Drug Combination'}, {'id': 'D004176', 'term': 'Dipyridamole'}], 'ancestors': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-04'}, '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': '2000-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve at steady state (AUCss)', 'timeFrame': 'Up to 144 hours after drug administration'}, {'measure': 'Percentage peak trough fluctuation (%PTF)', 'timeFrame': 'Up to 144 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration at steady state (Cmax,ss) of dipyridamole (dp)', 'timeFrame': 'Up to 144 hours after drug administration'}, {'measure': 'Maximum plasma concentration at steady state / Area under the plasma concentration-time curve at steady state ((Cmax,ss) / (AUCss)) of dipyridamole', 'timeFrame': 'Up to 144 hours after drug administration'}, {'measure': 'Time to reach maximum plasma concentration at steady state (tmax,ss) of dipyridamole', 'timeFrame': 'Up to 144 hours after drug administration'}, {'measure': 'Fluctuation of AUC (AUCfluct) of dipyridamole', 'timeFrame': 'Up to 144 hours after drug administration'}, {'measure': 'Terminal half-life in the analyte (t1/2) of dipyridamole', 'timeFrame': 'Up to 144 hours after drug administration'}, {'measure': 'Urinary excretion (Ae%) of dp, dipyridamole glucuronide (dp-gluc) and salicylic acid (SA)', 'timeFrame': 'Up to 106 hours after drug administration'}, {'measure': 'Number of participants with abnormal changes in clinical laboratory parameters', 'timeFrame': 'Up to day 7 after last drug administration'}, {'measure': 'Number of participants with Adverse Events', 'timeFrame': 'Up to day 7 after last drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Comparative Pharmacokinetics of Asasantin Extended Release (ER) and of immediate release Persantin tablets combined with Acetyl salicylic acid (ASA) tablets'}, '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 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 disorder\n* Surgery of the gastro-intestinal tract (except appendectomy)\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* Chronic or relevant acute infections\n* History or 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 result 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 or during the trial)\n* Excessive physical activities (\\<=5 days prior to administration or during the trial)\n* History of hemorrhagic diseases\n* History of gastro-intestinal ulcer, perforation or bleeding\n* History of bronchial asthma\n* Any laboratory value outside the reference range of clinical relevance\n\nFor female subjects:\n\n* Pregnancy\n* Positive pregnant test\n* No adequate contraception (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': 'NCT02273505', 'briefTitle': 'Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) and in a Combination of Persantin Immediate Release Tablets and ASA Tablets in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Comparison of Pharmacokinetics of Dipyridamole in Asasantin Extended Release (ER) 200/25 mg Capsules Bid and in a Combination of Persantin Immediate Release Tablets (100 mg Qid) and ASA Tablets (25 mg Bid) in an Open, Randomized, 2-way Crossover Study in Healthy Subjects', 'orgStudyIdInfo': {'id': '9.138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asasantin (ER)', 'interventionNames': ['Drug: Asasantin (ER)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination of Persantin and ASA', 'interventionNames': ['Drug: Persantin', 'Drug: Acetyl salicylic acid (ASA)']}], 'interventions': [{'name': 'Asasantin (ER)', 'type': 'DRUG', 'armGroupLabels': ['Asasantin (ER)']}, {'name': 'Persantin', 'type': 'DRUG', 'armGroupLabels': ['Combination of Persantin and ASA']}, {'name': 'Acetyl salicylic acid (ASA)', 'type': 'DRUG', 'armGroupLabels': ['Combination of Persantin and ASA']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}