Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-05 @ 1:11 PM
Study NCT ID:
NCT02172261
Status:
COMPLETED
Last Update Posted:
2014-06-24
First Post:
2014-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'C057619', 'term': 'glimepiride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-20', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773', 'timeFrame': 'up to 5 days'}, {'measure': 'Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773', 'timeFrame': 'up to 5 days'}, {'measure': 'AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of glimepiride', 'timeFrame': 'up to 4 days'}, {'measure': 'Cmax (maximum measured concentration of the analyte in plasma) of glimepiride', 'timeFrame': 'up to 4 days'}], '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) of glimepiride', 'timeFrame': 'up to 4 days'}, {'measure': 'tmax (time from dosing to the maximum concentration of the analyte in plasma) of glimepiride', 'timeFrame': 'up to 4 days'}, {'measure': 'λz (terminal rate constant in plasma) of glimepiride', 'timeFrame': 'up to 4 days'}, {'measure': 't½ (terminal half-life of the analyte in plasma) of glimepiride', 'timeFrame': 'up to 4 days'}, {'measure': 'MRTpo (mean residence time of the analyte in the body after po administration) of glimepiride', 'timeFrame': 'up to 4 days'}, {'measure': 'CL/F (apparent clearance of the analyte in the plasma after extravascular administration) of glimepiride', 'timeFrame': 'up to 4 days'}, {'measure': 'Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of glimepiride', 'timeFrame': 'up to 4 days'}, {'measure': 'tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 10773', 'timeFrame': 'up to 5 days'}, {'measure': 'Aet1-t2 (amount of analyte eliminated in urine over the time interval from t1 to t2) of glimepiride', 'timeFrame': '1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1'}, {'measure': 'fet1-t2 (fraction of analyte excreted unchanged in urine over the time interval from t1 to t2) of glimepiride', 'timeFrame': '1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1'}, {'measure': 'CLR (renal clearance of the analyte) of glimepiride', 'timeFrame': '1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1'}, {'measure': 'λz,ss (terminal rate constant of analyte in plasma at steady-state) of BI 10773', 'timeFrame': 'up to 5 days'}, {'measure': 't½,ss (terminal half-life of analyte in plasma at steady-state) of BI 10773', 'timeFrame': 'up to 5 days'}, {'measure': 'MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) of BI 10773', 'timeFrame': 'up to 5 days'}, {'measure': 'CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) of BI 10773', 'timeFrame': 'up to 5 days'}, {'measure': 'Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) of BI 10773', 'timeFrame': 'up to 5 days'}, {'measure': 'Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ) of BI 10773', 'timeFrame': '1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5'}, {'measure': 'fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ) of BI 10773', 'timeFrame': '1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5'}, {'measure': 'CLR,ss (renal clearance of the analyte at steady state) of BI 10773', 'timeFrame': '1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on day 1 and 5'}, {'measure': 'UGE0-24 (Urinary glucose excretion of the analyte in urine over the time interval from time zero to 24 h)', 'timeFrame': '1 hour pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 after administration on days 1 and 5'}, {'measure': 'Number of patients with abnormal findings in physical examination', 'timeFrame': 'Baseline and within 3-14 days after last glimepiride administration'}, {'measure': 'Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)', 'timeFrame': 'Baseline, day 1 and within 3-14 days after last glimepiride administration'}, {'measure': 'Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)', 'timeFrame': 'Baseline, day 1 and within 3-14 days after last glimepiride administration'}, {'measure': 'Number of patients with abnormal findings in clinical laboratory tests', 'timeFrame': 'Baseline, day 1,4 and within 3-14 days after last glimepiride administration'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'Up to 34 days'}, {'measure': 'Assessment of tolerability by investigator on a 4-point scale', 'timeFrame': 'Within 3-14 days after last glimepiride administration'}, {'measure': 'Number of patients with abnormal findings in glucose bedside tests', 'timeFrame': 'Pre-dose and 1, 2, 4, 7, 10, 14, 24 hours after glimepiride administration on day 1'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective was to investigate whether there was a drug-drug interaction between BI 10773 and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773 and glimepiride were determined when both drugs were given in combination compared to multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride given alone.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests\n* Age 18 to 50 years (incl.)\n* BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)\n* Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including BP (Blood Pressure, PR (Pulse Rate) and ECG (Electrocardiogram)) 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* 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 on trial days\n* Alcohol abuse (more than 30 g/day)\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* Glucose-6-phosphate dehydrogenase deficiency'}, 'identificationModule': {'nctId': 'NCT02172261', 'briefTitle': 'Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability of Both BI 10773 and Glimepiride After Co-administration Compared to Multiple Oral Doses of BI 10773 (50 mg q.d.) Alone and a Single Dose of Glimepiride (1 mg) Alone in Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)', 'orgStudyIdInfo': {'id': '1245.7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence ABC', 'description': '1. Treatment A: BI 10773 once daily from day 1 to 5\n2. Treatment B: BI 10773 and glimepiride once on day 1\n3. Treatment C: Glimepiride once on day 1', 'interventionNames': ['Drug: BI 10773', 'Drug: Glimepiride']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence CAB', 'description': '1. Treatment C: Glimepiride once on day 1\n2. Treatment A: BI 10773 once daily from day 1 to 5\n3. Treatment B: BI 10773 and glimepiride once on day 1', 'interventionNames': ['Drug: BI 10773', 'Drug: Glimepiride']}], 'interventions': [{'name': 'BI 10773', 'type': 'DRUG', 'armGroupLabels': ['Sequence ABC', 'Sequence CAB']}, {'name': 'Glimepiride', 'type': 'DRUG', 'armGroupLabels': ['Sequence ABC', 'Sequence CAB']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}