Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-27 @ 10:22 PM
Study NCT ID:
NCT06834451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Revolade® Eltrombopag 50 mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C520809', 'term': 'eltrombopag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Bioequivalence study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Outcome Measures', 'timeFrame': '0- 6 hours', 'description': 'Peak Plasma Concentration (Cmax)'}, {'measure': 'Pharmacokinetic Outcome Measures', 'timeFrame': '0 - 6 hours', 'description': 'Area under the plasma concentration versus time curve (AUC)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bioequivalence'], 'conditions': ['Healthy', 'Healthy Donors']}, 'descriptionModule': {'briefSummary': 'Bioequivalence Study', 'detailedDescription': 'A bioequivalence study of Eltrombopag will be developed in 30 healthy subjects, under fasting condition, following the design:\n\nOpen-label, crossover, randomized, single-dose design of 50 mg Eltrombopag tablets/immediate release tablets, with two treatments, two periods, two sequences in healthy volunteers in fasting condition, with a washout time of 15 days between each dose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men between 18 and 50 years of age. Have been clinically diagnosed as healthy by the trial physician. Subjects with clinical laboratory results requested in the protocol (Table 2) within normal ranges and/or fit by medical screening. Current for 3 months.\n\nSubjects non-smokers for the last 3 months. Having signed the informed consent. Subjects sexually active or of reproductive age must use an effective contraceptive method during and for at least 7 days after the end of the study.\n\nBody mass index between 18-30 kg/m2 at the time of inclusion in the study. Subject with complete contact information (cell phone and/or landline contact, address, email).\n\nSubject who has a family member or guardian with a contact telephone number. Subject with the availability of time to comply with the scheduled visits and activities.\n\nExclusion Criteria:\n\n* Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease.\n\nWoman in a state of pregnancy or breastfeeding. Subject diagnosed with hematological disorders, such as anemias and/or polycythemia.\n\nSubjects with a history of gastric surgeries. Permanent or temporary use during the last 15 days of any type of medication either on their own initiative or by medical prescription. Except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the start of the present trial.\n\nConsumption of xanthines from coffee, tea or chocolate during the 48 hours prior to hospitalization.\n\nDrinking alcohol in excess of 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days prior to hospitalization.\n\nConsumption of drugs of abuse or psychoactive substances reported as positive test at the time of hospitalization.\n\nKnown hypersensitivity to the active ingredient or excipients of the test product.\n\nMedical history of angioedema or anaphylaxis. Subject diagnosed with human immunodeficiency virus infection, hepatitis B or hepatitis C positive.\n\nHaving participated in clinical studies in the 4 months prior to the time of signing the informed consent.\n\nHaving donated blood in the 30 days prior to the time of signing the informed consent.'}, 'identificationModule': {'nctId': 'NCT06834451', 'acronym': 'Eltrombopag', 'briefTitle': 'Bioequivalence Study of Revolade® Eltrombopag 50 mg', 'organization': {'class': 'NETWORK', 'fullName': 'Centro de Atencion e Investigacion Medica'}, 'officialTitle': 'Bioequivalence Study of Revolade® Eltrombopag 50 mg Tablets - Novartis Vs Myelone ® Eltrombopag 50 mg Tablets - Colompack / Immediate Release Tablets in Healthy Subjects Under Fasting Condition', 'orgStudyIdInfo': {'id': 'ELTROM-BIO-001-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Period 1', 'description': 'Revolade® Reference', 'interventionNames': ['Drug: Revolade®', 'Drug: Eltrombopag (EPAG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Period 2', 'description': 'Eltrombopag TEST', 'interventionNames': ['Drug: Revolade®', 'Drug: Eltrombopag (EPAG)']}], 'interventions': [{'name': 'Revolade®', 'type': 'DRUG', 'otherNames': ['Eltrombopag'], 'description': 'Tableta 50 mg Reference', 'armGroupLabels': ['Period 1', 'Period 2']}, {'name': 'Eltrombopag (EPAG)', 'type': 'DRUG', 'description': 'Tableta 50 mg', 'armGroupLabels': ['Period 1', 'Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111156', 'city': 'Chía', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Centro de Atención e Investigación Médica', 'geoPoint': {'lat': 4.85876, 'lon': -74.05866}}]}, 'ipdSharingStatementModule': {'url': 'https://www.caimed.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Oct 2024 - Oct 2025', 'ipdSharing': 'YES', 'description': 'All collected IPD, all IPD that underlie results in a publication', 'accessCriteria': 'Indicate whether a proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro de Atencion e Investigacion Medica', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principla Investigator', 'investigatorFullName': 'Humberto Reynales MD MSc PhD', 'investigatorAffiliation': 'Centro de Atencion e Investigacion Medica'}}}}