Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT02250833
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2014-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CKD-828 (80/5mg) Pharmacokinetic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'C542574', 'term': 'levamlodipine'}], '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': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2014-09-22', 'studyFirstSubmitQcDate': '2014-09-24', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.', 'timeFrame': 'up to 168 hours post dose'}, {'measure': 'AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.', 'timeFrame': 'up to 168 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.', 'timeFrame': 'up to 168 hours post dose'}, {'measure': 't1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.', 'timeFrame': 'up to 168 hours post dose'}, {'measure': 'AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.', 'timeFrame': 'up to 168 hours post dose'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'up to 31days post dose', 'description': '* Adverse Event monitoring\n* Evaluated safety parameters included: Physical examination, Vital sign, ECG, laboratory test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'CKD-828', 'Telmisartan', 'S-amlodipine', 'Pharmacokinetic'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, single-dose, two-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A healthy volunteer between 20 and 55 years old\n* More than 50kg and within 20% of ideal body weight\n* No any congenital or chronic diseases and medical symptom\n* Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration\n* Signed the informed consent form prior to the study participation.\n\nExclusion Criteria:\n\n* History of relevant hypersensitivity against drug\n* Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)\n* Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin \\> 1.5\\*ULN)\n* SBP \\<90mmHg or SBP \\>150mmHg\n* DBP \\<50mmHg or DBP \\>100mmHg\n* Creatinine clearance \\<80mL/min\n* A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug\n* The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration.\n* A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day)\n* Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration\n* Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug'}, 'identificationModule': {'nctId': 'NCT02250833', 'briefTitle': 'CKD-828 (80/5mg) Pharmacokinetic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'To Compare the Pharmacokinetics and Safety of CKD-828 80/5mg to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '130HPS14006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CKD-828(Fixed Dose Combination)', 'description': 'FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg', 'interventionNames': ['Drug: CKD-828']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination Therapy', 'description': 'Coadministration of Telmisartan 80mg and S-amlodipine 5mg', 'interventionNames': ['Drug: Telmisartan', 'Drug: S-amlodipine']}], 'interventions': [{'name': 'CKD-828', 'type': 'DRUG', 'otherNames': ['Telminuvo'], 'description': 'Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily', 'armGroupLabels': ['CKD-828(Fixed Dose Combination)']}, {'name': 'Telmisartan', 'type': 'DRUG', 'otherNames': ['Micardis'], 'description': '\\- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)', 'armGroupLabels': ['Combination Therapy']}, {'name': 'S-amlodipine', 'type': 'DRUG', 'otherNames': ['Anydipine s'], 'description': '\\- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)', 'armGroupLabels': ['Combination Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Daegu, Samdeok-dong, 2-ga 50', 'state': 'Samdeok-dong, 2-ga 50 Jung-gu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital'}], 'overallOfficials': [{'name': 'Young-Ran Yoon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital Clinical Trial Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}