Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT03914534
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Sodium Divalproate Tablets 500 mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '(AUC) Area Under the Curve 0-48', 'timeFrame': 'From 0 to 48 hours', 'description': '0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours'}, {'measure': 'Cmax', 'timeFrame': 'From 0 to 48 hours', 'description': '0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'From 0 to 48 hours', 'description': '0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours'}, {'measure': 'Kel', 'timeFrame': 'From 0 to 48 hours', 'description': '0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.', 'detailedDescription': 'This will be a single-center, open-label, four-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 30 healthy adults will be randomized to receive a single dose (500 mg) of the test formulation of valproic acid and reference formulation of valproic acid separately in each treatment period. There will be two treatment sequences (AB, BA) and a 7 day washout between the two treatment periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women from 18 to 50 years old\n* Diagnosed as healthy after a clinical examination\n* BMI from 18 to 30 kg/m2\n* Not smoking for at least 3 months\n* To sign the informed consent\n* Not having participated in a similar study for at least 4 months\n\nExclusion Criteria:\n\n* Renal, cardiac immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric condition\n* Hematologic disorders, specially anemia and polycythemia\n* Permanent or temporal pharmacological therapy, prescribed or not\n* Smoking for the last 3 months\n* Alcohol drinker more than once a week\n* Drug abuse\n* Drug hypersensitivity\n* Angioedema or anaphylaxis history\n* Pregnancy or breast-feeding\n* HIV o Hepatitis B diagnosed\n* Blood donor in the past 30 days'}, 'identificationModule': {'nctId': 'NCT03914534', 'briefTitle': 'Bioequivalence Study of Sodium Divalproate Tablets 500 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tecnoquimicas'}, 'officialTitle': 'Bioequivalence Study of Sodium Divalproate Tablets 500 mg', 'orgStudyIdInfo': {'id': 'Versión 1- BIO 088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Formulation of Valproic Acid', 'description': 'Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2', 'interventionNames': ['Drug: Valproic Acid 500 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Formulation of Valproic Acid', 'description': 'Valcote tablets 500 mg Single dose administered in dosing period 1 or 2', 'interventionNames': ['Drug: Valcote 500 mg']}], 'interventions': [{'name': 'Valproic Acid 500 MG', 'type': 'DRUG', 'description': 'Administration of 500 mg of Valproic Acid', 'armGroupLabels': ['Test Formulation of Valproic Acid']}, {'name': 'Valcote 500 mg', 'type': 'DRUG', 'description': 'Administration of 500 mg of Valproic Acid', 'armGroupLabels': ['Reference Formulation of Valproic Acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chía', 'country': 'Colombia', 'facility': 'Universidad de la Sabana', 'geoPoint': {'lat': 4.85876, 'lon': -74.05866}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tecnoquimicas', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}