Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-03 @ 4:03 AM
Study NCT ID:
NCT02214966
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2014-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Food on the Bioavailability of Telmisartan / Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'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': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-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': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2014-08-12', 'studyFirstSubmitQcDate': '2014-08-12', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-∞ (area under the concentration-time curve of the analytes in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'AUC0-24 (area under the concentration-time curve of the analytes in plasma over one dosing interval from 0 to 24h)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'Cmax (maximum measured concentration of the analytes in plasma)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'AUC0-tz (area under the concentration-time curve of ramipril in plasma over the time interval from 0 to the time of the last quantifiable data point)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'tmax (time from dosing to the maximum concentration of the analytes in plasma)', 'timeFrame': 'up to 96 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'λz (terminal rate constant in plasma)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 't1/2 (terminal half-life of the three analytes in plasma)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'MRTpo (mean residence time of the analytes in the body after po administration)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'CL/F (apparent clearance of the analytes in the plasma after extravascular administration)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 54 days'}, {'measure': 'Assessment of tolerability by investigator on a 4-point scale', 'timeFrame': 'Day 5 of each treatment period'}, {'measure': 'Number of patients with clinically significant changes in Vital Signs (Blood Pressure, Pulse Rate)', 'timeFrame': 'up to 54 days'}, {'measure': 'Number of patients with clinically significant changes in laboratory tests', 'timeFrame': 'up to 54 days'}, {'measure': 'Number of patients with clinically significant changes in Electrocardiogram (ECG)', 'timeFrame': 'up to 54 days'}, {'measure': 'AUC0-tz (area under the concentration-time curve of ramiprilat and telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point)', 'timeFrame': 'up to 96 hours after drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective was to investigate the relative bioavailability of the fixed dose combination (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the bioavailability of the FDC tablet while fasting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests\n* Age ≥18 and ≤55 years\n* Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2\n* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance\n* Any evidence of a clinically relevant concomitant disease\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Surgery of the gastrointestinal tract (except appendectomy)\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* History of relevant orthostatic hypotension, fainting spells or blackouts\n* Chronic or relevant acute infections\n* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)\n* Intake of drugs with a long half-life (\\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial\n* Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial\n* Participation in another trial with an investigational drug within two months prior to administration or during the trial\n* Smoker (\\>10 cigarettes or \\>3 cigars or \\>3 pipes/day)\n* Inability to refrain from smoking during 24 hours prior to dosing and 24 hours after dosing\n* Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point\n* Drug abuse\n* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)\n* Excessive physical activities (within one week prior to administration of trial drug or during the trial)\n* Any laboratory value outside the reference range that is of clinical relevance\n* Inability to comply with dietary regimen of trial site\n* A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval \\>450 ms)\n* A history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalemia, hypokalemia, family history of Long QT Syndrome)\n* Any history of relevant low BP\n* Supine blood pressure at screening of systolic \\<110 mm Hg and diastolic \\<60 mm Hg\n* History of urticaria\n* History of angioneurotic edema\n* Hereditary fructose intolerance\n* Salt and/or volume depletion\n\nFor female subjects:\n\n* Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion\n* No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment) or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)\n* Currently lactating'}, 'identificationModule': {'nctId': 'NCT02214966', 'briefTitle': 'Influence of Food on the Bioavailability of Telmisartan / Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Influence of Food on the Bioavailability of 80 mg Telmisartan / 10 mg Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-sequence, Two-period Crossover Study)', 'orgStudyIdInfo': {'id': '1236.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telmisartan/Ramipril, fed', 'interventionNames': ['Drug: Telmisartan/Ramipril, fixed dose combination tablet', 'Other: high fat, high caloric meal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan/Ramipril, fasted', 'interventionNames': ['Drug: Telmisartan/Ramipril, fixed dose combination tablet']}], 'interventions': [{'name': 'Telmisartan/Ramipril, fixed dose combination tablet', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan/Ramipril, fasted', 'Telmisartan/Ramipril, fed']}, {'name': 'high fat, high caloric meal', 'type': 'OTHER', 'armGroupLabels': ['Telmisartan/Ramipril, fed']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}