Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-26 @ 12:40 AM
Study NCT ID:
NCT01366235
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2011-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C023676', 'term': 'chloroquine diphosphate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-02', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pharmacokinetic evaluation', 'timeFrame': 'within 30 days', 'description': 'maximum of concentration(Cmax)'}], 'secondaryOutcomes': [{'measure': 'pharmacokinetic evaluations', 'timeFrame': 'within 30 days', 'description': 'Area under the time-concentration curve(AUC)'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://crc.amc.seoul.kr', 'label': 'Clinical Research Center, Asan Medical Center'}]}, 'descriptionModule': {'briefSummary': 'Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic differences of therapeutic effect of chloroquine and search the cause of these ethnic differences. For this purpose, chloroquine will be administered to four ethic groups of Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be measured. The result of this study will be helpful in finding more adequate dosing regimen of chloroquine in patients with malaria.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 20 - 50 male subjects (6 Koreans, 6 Caucasians, 6 Africans and 6 Southeast Asians)\n* Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height \\[cm\\] - 100)x0.9.\n\nExclusion Criteria:\n\n* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.\n* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.'}, 'identificationModule': {'nctId': 'NCT01366235', 'briefTitle': 'Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug', 'orgStudyIdInfo': {'id': '2011-0214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Southeast Asians', 'interventionNames': ['Drug: chloroquine phosphate 1000 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Korean', 'interventionNames': ['Drug: chloroquine phosphate 1000 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Caucasians', 'interventionNames': ['Drug: chloroquine phosphate 1000 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Africans', 'interventionNames': ['Drug: chloroquine phosphate 1000 mg']}], 'interventions': [{'name': 'chloroquine phosphate 1000 mg', 'type': 'DRUG', 'description': '1000 mg, 1day', 'armGroupLabels': ['Africans', 'Caucasians', 'Korean', 'Southeast Asians']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}}}}