Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-18 @ 6:39 AM
Study NCT ID:
NCT02214992
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2014-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to 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': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, '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': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'Cmax (maximum measured concentration of the analyte in plasma)', 'timeFrame': 'up to 96 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'AUC0-tz (area under the concentration-time curve of the analyte 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': 'AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'tmax (time from dosing to the maximum concentration of the analyte in plasma)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'λz (terminal rate constant in plasma)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 't1/2 (terminal half-life of the analyte in plasma)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'MRTpo (mean residence time of the analyte in the body after po administration)', 'timeFrame': 'up to 96 hours after drug administration'}, {'measure': 'CL/F (apparent clearance of the analyte 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 78 days'}, {'measure': 'Number of patients with clinically relevant changes in laboratory tests', 'timeFrame': 'up to 78 days'}, {'measure': 'Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate)', 'timeFrame': 'up to 78 days'}, {'measure': 'Number of patients with clinically relevant changes in 12-lead Electrocardiogram (ECG)', 'timeFrame': 'up to 78 days'}, {'measure': 'Assessment of ttolerability by investigator on a 4-point scale', 'timeFrame': 'Day 5 of each treatment'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose combination versus its monocomponents given concurrently'}, '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 Age ≤ 55 years\n* BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)\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 (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) 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, 96 hours after dosing\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 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 blood pressure\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\nFor female subjects:\n\n* Pregnancy or planning to become pregnant during the study or within 2 months of study completion\n* Positive pregnancy test\n* Are not willing or are unable to use a reliable method of contraception (such as implants, injectables and combined oral contraceptives, sterilisation, intrauterine device, double barrier method, sexual abstinence) for at least 1 month prior to participation in the trial, during and up to 1 month after completion/termination of the trial\n* Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception\n* Currently lactating'}, 'identificationModule': {'nctId': 'NCT02214992', 'briefTitle': 'Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioequivalence of 80 mg Telmisartan / 10 mg Ramipril Fixed Dose Combination Compared With the Monocomponents, Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Three-way Crossover Study)', 'orgStudyIdInfo': {'id': '1236.5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telmisartan/Ramipril', 'description': 'Fixed dose combination tablet', 'interventionNames': ['Drug: Telmisartan/Ramipril']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan + Ramipril capsule', 'interventionNames': ['Drug: Telmisartan', 'Drug: Ramipril capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan + Ramipril tablet', 'interventionNames': ['Drug: Telmisartan', 'Drug: Ramipril tablet']}], 'interventions': [{'name': 'Telmisartan/Ramipril', 'type': 'DRUG', 'description': 'Fixed dose combination tablet', 'armGroupLabels': ['Telmisartan/Ramipril']}, {'name': 'Telmisartan', 'type': 'DRUG', 'otherNames': ['Micardis®'], 'armGroupLabels': ['Telmisartan + Ramipril capsule', 'Telmisartan + Ramipril tablet']}, {'name': 'Ramipril capsule', 'type': 'DRUG', 'otherNames': ['Altace®'], 'armGroupLabels': ['Telmisartan + Ramipril capsule']}, {'name': 'Ramipril tablet', 'type': 'DRUG', 'otherNames': ['Delix®'], 'armGroupLabels': ['Telmisartan + Ramipril tablet']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}