Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-27 @ 5:16 PM
Study NCT ID:
NCT02543606
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2015-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Two Formulations of Esomeprazole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-04', 'studyFirstSubmitDate': '2015-08-24', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The pharmacokinetic parameters of ln transformed data ln(AUC) of the product.', 'timeFrame': 'pre-dose to 12 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Bioequivalence of Two Formulations of Esomeprazole 40mg', 'detailedDescription': 'A randomized, two-way crossover, single-dose pharmacokinetic study to evaluate the bioequivalence of a test formulation of Esomelone powder for solution for injection/infusion 40mg (Esomeprazole 40mg), compared to an equivalent dose of a reference drug product (Nexium powder for injection and infusion 40mg) in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult, aged between 20 to 40 years old.\n2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest x-ray and electrocardiogram.\n\n * no particular clinical significance in clinical examination and laboratory tests within two months (60 days) prior to Period I dosing.\n * normal or considered not clinically significant by the investigator chest X-ray and ECG results within six months (180 days ) prior to Period I dosing.\n3. The normal range of the body mass index should be between 18.5 and 25; body mass index equals \\[weight (kg)\\]/\\[height (m)\\]2.\n4. Normal laboratory determinations result (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.\n5. Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.\n6. Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria.\n7. Female subject who is\n\n * using adequate contraception since last menstruation and no plan for conception during the study,\n * non-lactating.\n * has negative pregnancy test (urine) within 14 days prior to the study.\n8. Informed consent form signed.\n\nExclusion Criteria:\n\n1. A history of drug or alcohol abuse during the past 24 weeks.\n2. Sensitivity to analogous drug.\n3. A clinically significant illness (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, melaena or gastric ulcer) within the past 4 weeks.\n4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.\n5. Planned vaccination during the time course of the study.\n6. Participation of ant clinical investigation during the last 60 days.\n7. Regular use of any medication during the last 4 weeks.\n8. Single use of any medication during the last 2 weeks.\n9. Blood donation of more than 250 mL within the past 12 weeks.\n10. Individuals are judged by the investigation or co-investigator to be undesirable as subjects.'}, 'identificationModule': {'nctId': 'NCT02543606', 'briefTitle': 'Bioequivalence of Two Formulations of Esomeprazole', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yung Shin Pharm. Ind. Co., Ltd.'}, 'officialTitle': 'A Randomized, Two-way Crossover, Single-dose Pharmacokinetic Study to Evaluate the Bioequivalence of Esomelone for Injection/Infusion (Esomeprazole 40mg), Compared to Reference Drug (Nexium 40mg) in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'YSP-RFH3002-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esomelone', 'description': 'powder for injection/ infusion Esomeprazole 40mg', 'interventionNames': ['Drug: Esomelone', 'Drug: Nexium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nexium', 'description': 'powder for injection/ infusion Esomeprazole 40mg', 'interventionNames': ['Drug: Esomelone', 'Drug: Nexium']}], 'interventions': [{'name': 'Esomelone', 'type': 'DRUG', 'description': 'powder for injection/ infusion Esomeprazole 40mg', 'armGroupLabels': ['Esomelone', 'Nexium']}, {'name': 'Nexium', 'type': 'DRUG', 'description': 'powder for injection/ infusion Esomeprazole 40mg', 'armGroupLabels': ['Esomelone', 'Nexium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Hong-Zen Yeh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yung Shin Pharm. Ind. Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}