Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-27 @ 10:42 AM
Study NCT ID:
NCT01443208
Status:
COMPLETED
Last Update Posted:
2012-01-02
First Post:
2011-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
Sponsor:
Organization:
Raw JSON
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and a total body weight \\>50 kg (110 lbs)\n\nExclusion Criteria:\n\n* Elevated risk of suicide, in the opinion of the investigator or expert consultant\n* Pregnant or nursing females\n* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception'}, 'identificationModule': {'nctId': 'NCT01443208', 'briefTitle': 'Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects', 'orgStudyIdInfo': {'id': 'B2061137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 mg', 'interventionNames': ['Drug: desvenlafaxine']}, {'type': 'EXPERIMENTAL', 'label': '100 mg', 'interventionNames': ['Drug: desvenlafaxine']}, {'type': 'EXPERIMENTAL', 'label': '200 mg', 'interventionNames': ['Drug: desvenlafaxine']}], 'interventions': [{'name': 'desvenlafaxine', 'type': 'DRUG', 'description': 'one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days', 'armGroupLabels': ['50 mg']}, {'name': 'desvenlafaxine', 'type': 'DRUG', 'description': 'one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days', 'armGroupLabels': ['100 mg']}, {'name': 'desvenlafaxine', 'type': 'DRUG', 'description': 'two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days', 'armGroupLabels': ['200 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}