Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-04-17 @ 12:32 AM
Study NCT ID:
NCT01490658
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2011-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072379', 'term': 'repaglinide'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2011-12-08', 'studyFirstSubmitQcDate': '2011-12-09', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration'}, {'measure': 'Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet'}, {'measure': 'Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration'}, {'measure': 'NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet'}], 'secondaryOutcomes': [{'measure': 'Repaglinide AUC after NN4440 (1/500) during fed state'}, {'measure': 'Repaglinide Cmax after NN4440 ((1/500) during fed state'}, {'measure': 'Change in physical examinations from screening'}, {'measure': 'Vital signs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '18666804', 'type': 'RESULT', 'citation': 'Hoelscher D, Chu PL, Lyness W. Fixed-dose combination tablet of repaglinide and metformin is bioequivalent to concomitantly administered individual tablets of repaglinide and metformin : randomized, single-blind, three-period crossover study in healthy subjects. Clin Drug Investig. 2008;28(9):573-82. doi: 10.2165/00044011-200828090-00004.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and as a combination tablet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)\n* BMI (Body Mass Index) between 19-29 kg/m\\^2, both inclusive\n* Fasting plasma glucose from 70-115 mg/dl\n* Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data\n\nExclusion Criteria:\n\n* Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease\n* Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening\n* Positive results on screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody\n* Positive results on the drug abuse/alcohol screen\n* Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose administration) and for the duration of the study\n* Subject is currently a smoker (more than one cigarette per day or equivalent)\n* Use of grapefruit or grapefruit juice within 7 days of trial product dose administration\n* Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing'}, 'identificationModule': {'nctId': 'NCT01490658', 'briefTitle': 'Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomized, Single-Blind, Three-Period Crossover Study Examining the Single Dose Pharmacokinetics of Concomitantly Administered Repaglinide and Metformin Versus Combination Tablet Dosing (NN4440) in Fed Healthy Volunteers', 'orgStudyIdInfo': {'id': 'NN4440-1753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment period 1', 'interventionNames': ['Drug: repaglinide', 'Drug: metformin', 'Drug: repaglinide and metformin combination tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment period 2', 'interventionNames': ['Drug: repaglinide', 'Drug: metformin', 'Drug: repaglinide and metformin combination tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment period 3', 'interventionNames': ['Drug: repaglinide', 'Drug: metformin', 'Drug: repaglinide and metformin combination tablet']}], 'interventions': [{'name': 'repaglinide', 'type': 'DRUG', 'description': 'Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2', 'Treatment period 3']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2', 'Treatment period 3']}, {'name': 'repaglinide and metformin combination tablet', 'type': 'DRUG', 'description': 'Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods', 'armGroupLabels': ['Treatment period 1', 'Treatment period 2', 'Treatment period 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}