Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-28 @ 1:12 AM
Study NCT ID:
NCT01246193
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2010-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CKD-828(80/2.5mg) Pharmacokinetic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-17', 'studyFirstSubmitDate': '2010-11-17', 'studyFirstSubmitQcDate': '2010-11-21', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area under the plasma concentration-time curve (AUC) and Cmax after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.', 'timeFrame': 'up to 168 hours postdose'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CKD-828', 'Hypertension', 'Primary Hypertension', 'Healthy Volunteer', 'S-Amlodipine', 'Telmisartan', 'Amlodipine', 'Pharmacokinetic', 'Phase 1'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.\n* Have not any congenital or chronic diseases and medical symptom.\n* Appropriate for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening).\n* Able to participate in the entire trial.\n* Signed the informed consent form prior to the study participation.\n\nExclusion Criteria:\n\n* Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administraion.\n* The evidence of acute disease within 28 days prior to the first IP administraion.\n* Disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).\n* Relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.\n* Hypersensitivity Telmisartan or Amlodipine.\n* SBP\\<90mmHg or DBP\\<50mmHg.\n* Abnormal laboratory result(s): AST or ALT \\> 1.25 times of upper limit / Total bilirubin \\> 1.5 times of upper limit.\n* A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.\n* Diet(Especially, grapefruit juice-within 7 days prior to the first IP administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).\n* Donated whole blood within 60 days prior to the first IP administraion.\n* Participated in the other clinical trials within 90days prior to the first IP administraion.\n* Medicine within 10 days prior to the first IP administraion? Does the medication affect this trial.\n* A pregnant or nursing women who does not use medically acceptable birth control.\n* Appropriate for the trial judging from principal investigator."}, 'identificationModule': {'nctId': 'NCT01246193', 'briefTitle': 'CKD-828(80/2.5mg) Pharmacokinetic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Telmisatan 80mg and S-Amlodipine 2.5mg as a Fixed Dose Combination Tablet Compared With Combination Therapy in Healthy Volunteers', 'orgStudyIdInfo': {'id': '130HPS10C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CKD-828(Fixed Dose Combination)', 'description': 'Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg', 'interventionNames': ['Drug: CKD-828(FDC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination Therapy', 'description': 'Co-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine', 'interventionNames': ['Drug: Combination Therapy']}], 'interventions': [{'name': 'CKD-828(FDC)', 'type': 'DRUG', 'description': 'Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily', 'armGroupLabels': ['CKD-828(Fixed Dose Combination)']}, {'name': 'Combination Therapy', 'type': 'DRUG', 'description': 'Drug: Telmisatan 80mg Tablet, Oral, Once Daily\n\nDrug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily', 'armGroupLabels': ['Combination Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje Unuversity Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}], 'overallOfficials': [{'name': 'Eunyoung Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje Unuversity Pusan Paik Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jin Kim / Director', 'oldOrganization': 'Clincal Research Department'}}}}