Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 11:01 PM
Study NCT ID:
NCT01227603
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2010-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009543', 'term': 'Nifedipine'}, {'id': 'C081643', 'term': 'candesartan'}, {'id': 'C077793', 'term': 'candesartan cilexetil'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'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': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2010-10-22', 'studyFirstSubmitQcDate': '2010-10-22', 'lastUpdatePostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'Maximum drug concentration in plasma after dose administration for nifedipine and candesartan'}, {'measure': 'AUC(0-tn)', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'AUC from time 0 to the last data point for nifedipine and candesartan'}], 'secondaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan'}, {'measure': 'Cmax,norm', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan'}, {'measure': 'AUCnorm', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'Area under the curve divided by dose per kg body weight for nifedipine and candesartan'}, {'measure': 'AUC(0-48)', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'AUC from time 0 to time 48 h for nifedipine and candesartan'}, {'measure': 'tmax', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan'}, {'measure': 't½', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'Half-life associated with the terminal slope for nifedipine and candesartan'}, {'measure': 'MRT', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'Mean residence time for nifedipine and candesartan'}, {'measure': 'CL/f', 'timeFrame': 'Within 48 hours after each treatment', 'description': 'Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'Approximately 3.5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Nifedipine', 'Candesartan', 'FDC'], 'conditions': ['Hypertension, Essential']}, 'referencesModule': {'references': [{'pmid': '23849325', 'type': 'RESULT', 'citation': 'Brendel E, Weimann B, Dietrich H, Froede C, Thomas D. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions. Int J Clin Pharmacol Ther. 2013 Sep;51(9):753-62. doi: 10.5414/CP201879.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subject\n* Age: 18 to 45 years (inclusive) at the first screening / examination visit\n* Ethnicity: Caucasian\n* Body mass index (BMI): \\>/=18 and \\</=29,9 kg/m²\n\nExclusion Criteria:\n\n* Systolic blood pressure below 120 or above 145 mmHg\n* Diastolic blood pressure above 95 mmHg\n* Heart rate below 45 or above 95 beats / min\n* Clinically relevant findings in the physical examination\n* Suspicion of drug or alcohol abuse\n* Regular daily consumption of more than 1 L of xanthin-containing beverages\n* Intake of foods or beverages containing grapefruit within 4 weeks before the pre-study examination'}, 'identificationModule': {'nctId': 'NCT01227603', 'briefTitle': 'Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-way-crossover Design', 'orgStudyIdInfo': {'id': '14027'}, 'secondaryIdInfos': [{'id': '2010-021966-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nifedipine-candesartan FDC', 'description': 'Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.', 'interventionNames': ['Drug: Nifedipine-candesartan FDC (BAY 98-7106)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nifedipine and candesartan', 'description': 'Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.', 'interventionNames': ['Drug: Nifedipine GITS (Adalat LA, BAYA1040)', 'Drug: Candesartan (Atacand)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nifedipine', 'description': 'Each subject received one dose of nifedipine GITS 60 mg orally.', 'interventionNames': ['Drug: Nifedipine GITS (Adalat LA, BAYA1040)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Candesartan', 'description': 'Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.', 'interventionNames': ['Drug: Candesartan (Atacand)']}], 'interventions': [{'name': 'Nifedipine-candesartan FDC (BAY 98-7106)', 'type': 'DRUG', 'description': 'Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan', 'armGroupLabels': ['Nifedipine-candesartan FDC']}, {'name': 'Nifedipine GITS (Adalat LA, BAYA1040)', 'type': 'DRUG', 'description': 'Single oral dose of 1 tablet of nifedipine GITS 60 mg', 'armGroupLabels': ['Nifedipine', 'Nifedipine and candesartan']}, {'name': 'Candesartan (Atacand)', 'type': 'DRUG', 'description': 'Single oral dose of 32 mg (2 x 16 mg tablet) candesartan', 'armGroupLabels': ['Candesartan', 'Nifedipine and candesartan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51063', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}