Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT02112903
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'lastUpdateSubmitDate': '2014-11-12', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-04-11', 'lastUpdatePostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastro-intestinal tolerability (nausea) measured with 11-point Numerical Rating Scale', 'timeFrame': 'Up to 24 hours post-dose in each treatment period'}, {'measure': 'Gastro-intestinal tolerability (abdominal pain) measured with 11-point Numerical Rating Scale', 'timeFrame': 'Up to 24 hours post-dose in each treatment period'}, {'measure': 'Gastro-intestinal tolerability (abdominal discomfort) measured with 11-point Numerical Rating Scale', 'timeFrame': 'Up to 24 hours post-dose in each treatment period'}, {'measure': 'Frequency, severity and duration of reported gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort and abdominal pain)', 'timeFrame': 'Up to 72 hours post-dose in each treatment period'}, {'measure': 'Area under the vortioxetine plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)', 'timeFrame': 'Up to 72 hours postdose'}, {'measure': 'Maximum observed concentration (Cmax) of vortioxetine', 'timeFrame': 'Up to 72 hours postdose'}, {'measure': 'Nominal time corresponding to the occurrence of Cmax (tmax)', 'timeFrame': 'Up to 72 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Women']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the gastro-intestinal tolerability (nausea, vomiting, diarrhoea, abdominal discomfort, and abdominal pain) of vortioxetine following single oral doses of three modified-release (MR) capsules with differently coated multiple particles compared to one immediate-release (IR) tablet.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women ≥18 and ≤45 years of age with a body mass index (BMI) of \\>18.5 and \\<30.0 kg/m2.\n* Women will be of child-bearing potential with a confirmed non-pregnant and non-lactating status.\n\nOther protocol-defined Inclusion and Exclusion Criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02112903', 'briefTitle': 'Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Randomised, Double-blind 4-way Crossover Study Comparing the Gastro-intestinal Tolerability and Absorption Profile of Vortioxetine After Administration of Modified-release Formulations and Immediate-release Formulation in Healthy Women', 'orgStudyIdInfo': {'id': '15947A'}, 'secondaryIdInfos': [{'id': '2014-000121-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Encapsulated vortioxetine IR tablet, 20 mg', 'description': 'Single oral dose', 'interventionNames': ['Drug: Encapsulated vortioxetine IR tablet, 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine MR capsule 20 mg (pH 5.5)', 'description': 'Single oral dose', 'interventionNames': ['Drug: Vortioxetine MR capsule 20 mg (pH 5.5)']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine MR capsule 20 mg (pH 6.0)', 'description': 'Single oral dose', 'interventionNames': ['Drug: Vortioxetine MR capsule 20 mg (pH 6.0)']}, {'type': 'EXPERIMENTAL', 'label': 'Vortioxetine MR capsule 20 mg (pH 7.0)', 'description': 'Single oral dose', 'interventionNames': ['Drug: Vortioxetine MR capsule 20 mg (pH 7.0)']}], 'interventions': [{'name': 'Encapsulated vortioxetine IR tablet, 20 mg', 'type': 'DRUG', 'armGroupLabels': ['Encapsulated vortioxetine IR tablet, 20 mg']}, {'name': 'Vortioxetine MR capsule 20 mg (pH 5.5)', 'type': 'DRUG', 'armGroupLabels': ['Vortioxetine MR capsule 20 mg (pH 5.5)']}, {'name': 'Vortioxetine MR capsule 20 mg (pH 6.0)', 'type': 'DRUG', 'armGroupLabels': ['Vortioxetine MR capsule 20 mg (pH 6.0)']}, {'name': 'Vortioxetine MR capsule 20 mg (pH 7.0)', 'type': 'DRUG', 'armGroupLabels': ['Vortioxetine MR capsule 20 mg (pH 7.0)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GB801', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}