Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-09 @ 7:43 AM
Study NCT ID:
NCT02273518
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, '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': '2001-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)', 'timeFrame': 'Up to 48 hours after start of drug administration'}, {'measure': 'Percent peak trough fluctuation of dipyridamole in plasma (%PTF)', 'timeFrame': 'Up to 48 hours after start of drug administration'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration of the analytes in plasma at steady state (Cmax,ss)', 'timeFrame': 'Up to 48 hours after start of drug administration'}, {'measure': 'Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)', 'timeFrame': 'Up to 48 hours after start of drug administration'}, {'measure': 'Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)', 'timeFrame': 'Up to 48 hours after start of drug administration'}, {'measure': 'Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)', 'timeFrame': 'Up to 48 hours after start of drug administration'}, {'measure': 'Terminal half-life of the analytes in plasma (t1/2)', 'timeFrame': 'Up to 48 hours after start of drug administration'}, {'measure': 'Percent of dose of the analytes recovered unchanged in urine (Ae%)', 'timeFrame': 'Up to 24 hours after start of drug administration'}, {'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 48 hours after start of drug administration'}, {'measure': 'Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)', 'timeFrame': 'up to 8 days after last study drug administration'}, {'measure': 'Number of subjects with clinically relevant changes in 12-lead ECG', 'timeFrame': 'up to 8 days after last study drug administration'}, {'measure': 'Number of subjects with clinically relevant changes in laboratory values', 'timeFrame': 'up to 8 days after last study drug administration'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 8 days after last study drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)\n* Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent\n* Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG\n* Hematopoietic, hepatic and renal function tests will be carried out in the laboratory\n* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations\n* The above mentioned examinations will be performed within 14 days before the first administration of the test substance\n\nExclusion Criteria:\n\n* Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values\n* Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders\n* History of orthostatic hypotension, fainting spells or blackouts\n* Subjects with chronic or relevant acute infections\n* Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n* Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study\n* Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study\n* Volunteers who participate in another study with an investigational drug within the last two months preceding the study\n* Volunteers who are unable to refrain from smoking on study days\n* Volunteers who smoke more than10 cigarettes (or equivalent) per day\n* Volunteers who drink more than 60 g of alcohol per day\n* Volunteers who are dependent on drugs\n* Volunteers who donate blood (≥ 100 mL) within the last four weeks\n* Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)\n* Volunteers who suffer from any other disease or abnormality of clinical relevance\n* History of hemorrhagic diatheses\n* History of gastro-intestinal ulcer, perforation or bleeding\n* History of bronchial asthma\n* History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency\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': 'NCT02273518', 'briefTitle': 'Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers', 'orgStudyIdInfo': {'id': '9.144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asasantin ER, new formulation I', 'interventionNames': ['Drug: Asasantin ER, new formulation I']}, {'type': 'EXPERIMENTAL', 'label': 'Asasantin ER, new formulation II', 'interventionNames': ['Drug: Asasantin ER, new formulation II']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Asasantin ER, present commercial formulation', 'interventionNames': ['Drug: Asasantin ER, present commercial formulation']}], 'interventions': [{'name': 'Asasantin ER, new formulation I', 'type': 'DRUG', 'armGroupLabels': ['Asasantin ER, new formulation I']}, {'name': 'Asasantin ER, new formulation II', 'type': 'DRUG', 'armGroupLabels': ['Asasantin ER, new formulation II']}, {'name': 'Asasantin ER, present commercial formulation', 'type': 'DRUG', 'armGroupLabels': ['Asasantin ER, present commercial formulation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}