Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-31 @ 7:08 AM
Study NCT ID:
NCT04639804
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2020-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631239', 'term': 'tegoprazan'}, {'id': 'D009288', 'term': 'Naproxen'}, {'id': 'C056498', 'term': 'aceclofenac'}, {'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-20', 'studyFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCτ of tegoprazan and NSAIDs', 'timeFrame': 'pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7', 'description': 'Area under the plasma concentration-time curve during a steady-state dosing interval (τ) of tegoprazan and NSAIDs'}, {'measure': 'Css,max of tegoprazan and NSAIDs', 'timeFrame': 'pre-dose (0 hour) on Day1, Day5, Day6 and pre-dose up to 24 hours post-dose on Day7', 'description': 'Maximum Plasma Concentration at Steady State of tegoprazan and NSAIDs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['drug-drug interaction', 'pharmacokinetic'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '35787943', 'type': 'DERIVED', 'citation': 'Moon SJ, Shin N, Kang M, Kim B, Kim MG. Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects. Clin Ther. 2022 Jul;44(7):930-944.e1. doi: 10.1016/j.clinthera.2022.06.002. Epub 2022 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their combination in healthy male adults.', 'detailedDescription': 'A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult aged ≥ 19 and \\< 55 year-old at screening\n* Body mass index (BMI) ≥ 19.0 kg/m2 and \\< 27.0 kg/m2 with a body weight ≥ 55 kg at screening.\n\nExclusion Criteria:\n\n* History or evidence of clinically significant disease\n* History of GI disease or surgery that may affect the absorption of a drug\n* Laboratory test result which falls into the following values( ALT or AST \\> 2 × upper limit of normal (ULN))\n* History of regular alcohol consumption exceeding 210 g/week within 6 months\n* Daily use of ≥ 20 cigarettes within 6 months\n* Has taken any investigational agent within 6 months prior to the first dose of IMP\n* Subjects who are considered ineligible to participate in this study at the discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT04639804', 'briefTitle': 'Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'IN_APA_117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tegoprazan 50 mg', 'description': 'Multiple doses of tegoprazan alone once daily (QD) for 7 days', 'interventionNames': ['Drug: Tegoprazan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NSAIDs', 'description': 'Multiple doses of NSAIDs alone twice daily (BID) for 7 days', 'interventionNames': ['Drug: Naproxen', 'Drug: Aceclofenac', 'Drug: Celecoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tegoprazan 50 mg + NSAIDs', 'description': 'Multiple doses of tegoprazan QD in combination with NSAIDs BID for 7 days', 'interventionNames': ['Drug: Tegoprazan', 'Drug: Naproxen', 'Drug: Aceclofenac', 'Drug: Celecoxib']}], 'interventions': [{'name': 'Tegoprazan', 'type': 'DRUG', 'otherNames': ['K-CAB'], 'description': 'Tegoprazan 50 mg tablet', 'armGroupLabels': ['Tegoprazan 50 mg', 'Tegoprazan 50 mg + NSAIDs']}, {'name': 'Naproxen', 'type': 'DRUG', 'otherNames': ['Naxen-F'], 'description': 'Naproxen 500 mg tablet', 'armGroupLabels': ['NSAIDs', 'Tegoprazan 50 mg + NSAIDs']}, {'name': 'Aceclofenac', 'type': 'DRUG', 'otherNames': ['Airtal'], 'description': 'Aceclofenac 100 mg tablet', 'armGroupLabels': ['NSAIDs', 'Tegoprazan 50 mg + NSAIDs']}, {'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex 200 mg'], 'description': 'Celecoxib 200 mg capsule', 'armGroupLabels': ['NSAIDs', 'Tegoprazan 50 mg + NSAIDs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'overallOfficials': [{'name': 'Min-Gul Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}