Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-02 @ 10:06 AM
Study NCT ID:
NCT04066257
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631239', 'term': 'tegoprazan'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D013752', 'term': 'Tetracycline'}, {'id': 'D001729', 'term': 'Bismuth'}, {'id': 'C002791', 'term': 'bismuth tripotassium dicitrate'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004603', 'term': 'Elements, Radioactive'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D011868', 'term': 'Radioisotopes'}, {'id': 'D007554', 'term': 'Isotopes'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-22', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-12 of tegaprazan and metabolite M1', 'timeFrame': 'pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.', 'description': 'Area under the plasma concentration versus time curve of tegoprazan'}, {'measure': 'Cmax of tegaprazan and metabolite M1', 'timeFrame': 'pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.', 'description': 'Peak Plasma Concentration of tegoprazan and metabolite M1'}, {'measure': 'AUC0-6 of metronidazole, tetracycline and bismuth', 'timeFrame': 'pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.', 'description': 'Area under the plasma concentration versus time curve of metronidazole, tetracycline and bismuth'}, {'measure': 'Cmax of metronidazole, tetracycline and bismuth', 'timeFrame': 'pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.', 'description': 'Peak Plasma Concentration of metronidazole, tetracycline and bismuth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-Drug interaction', 'pharmacokinetic'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33637332', 'type': 'DERIVED', 'citation': 'Jeon JY, Kim SY, Moon SJ, Oh K, Lee J, Kim B, Song GS, Kim MG. Pharmacokinetic Interactions between Tegoprazan and Metronidazole/Tetracycline/Bismuth and Safety Assessment in Healthy Korean Male Subjects. Clin Ther. 2021 Apr;43(4):722-734. doi: 10.1016/j.clinthera.2021.01.026. Epub 2021 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.', 'detailedDescription': 'A open-label, randomized, multiple dose, two arm, two period, crossover study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult aged ≥ 19 and \\< 55 year-old on the day of obtaining the informed consent.\n* Body mass index (BMI) ≥ 17.5 kg/m2 and \\< 28.0 kg/m2 with a body weight ≥ 55 kg at screening.\n* H. pylori negative.\n\nExclusion Criteria:\n\n* Medical History\n\n 1. History or evidence of clinically significant disease\n 2. History of gastrointestinal disease (e.g., esophageal disease such as esophageal achalasia or stenosis, and Crohn's disease) or surgery that may affect the absorption of a drug.\n 3. History or presence of hypersensitivity to IMPs, components of IMPs, benzimidazoles, imidazole derivatives or tetracycline antibiotics\n* Laboratory tests(in blood)\n\n 1\\) Total bilirubin, AST (GOT), ALT (GPT) \\> 1.5 X upper limit of normal (ULN) at screening\n* History of drug/alcohol abuse\n* Participated in other study and received investigational product within 3 months prior to the first study dose.\n* taken a medication known to substantially induce or inhibit a drug metabolizing enzyme\n* Not able to use a medically acceptable contraceptive method throughout the study."}, 'identificationModule': {'nctId': 'NCT04066257', 'briefTitle': 'Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'An Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction After Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CJ_APA_111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tegoprazan 50 mg', 'description': 'Oral administration of Tegoprazan 50 mg twice daily for 7 days', 'interventionNames': ['Drug: Tegoprazan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg', 'description': 'Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg \\& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days', 'interventionNames': ['Drug: Tegoprazan', 'Drug: Metronidazole', 'Drug: Tetracycline', 'Drug: Bismuth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTN 500 mg+TCL 500 mg+BIS 300 mg', 'description': 'Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \\& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days', 'interventionNames': ['Drug: Metronidazole', 'Drug: Tetracycline', 'Drug: Bismuth']}], 'interventions': [{'name': 'Tegoprazan', 'type': 'DRUG', 'otherNames': ['K-CAB'], 'description': 'Tegoprazan 50 mg tablet', 'armGroupLabels': ['Tegoprazan 50 mg', 'Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg']}, {'name': 'Metronidazole', 'type': 'DRUG', 'otherNames': ['Flasinyl'], 'description': 'Metronidazole 250 mg tablet', 'armGroupLabels': ['MTN 500 mg+TCL 500 mg+BIS 300 mg', 'Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg']}, {'name': 'Tetracycline', 'type': 'DRUG', 'otherNames': ['Teracyclin'], 'description': 'Tetracycline hydrochloride 250 mg capsule', 'armGroupLabels': ['MTN 500 mg+TCL 500 mg+BIS 300 mg', 'Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg']}, {'name': 'Bismuth', 'type': 'DRUG', 'otherNames': ['Denol'], 'description': 'Tripotassium bismuth dicitrate 300 mg tablet', 'armGroupLabels': ['MTN 500 mg+TCL 500 mg+BIS 300 mg', 'Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg']}]}, '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', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}