Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-20 @ 4:51 AM
Study NCT ID:
NCT03657550
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2018-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542574', 'term': 'levamlodipine'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-21', 'size': 501644, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-14T19:33', 'hasProtocol': True}, {'date': '2018-09-08', 'size': 959838, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-14T19:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This study consists of 2 parts. Part 1 will be a randomized, open-label, single-dose, two-way crossover study to assess the relative BA of levamlodipine maleate tablets from CSPC versus Amlodipine Besylate Tablet NORVASC® from Pfizer Inc. after a single oral administration under fasted conditions in male and female healthy subjects. Part 2 will be a single-arm, open-label, single-dose phase to assess food effect on the PK profile of levamlodipine maleate tablets from CSPC. Subjects who have completed Part 1 will be rolled over to Part 2 after a wash-out period for at least 14-days since the last dosing. Subjects will receive a single oral administration of study drug under a high-fat / high-calorie meal that should derive approximately 150, 250 and 500-600 calories from protein, carbohydrate and fat, respectively.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2018-06-21', 'studyFirstSubmitQcDate': '2018-09-01', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The plasma concentration of study drugs', 'timeFrame': '6 weeks', 'description': 'Plasma concentration of study drugs will be measured at all the time points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study are (1) to assess the relative bioavailability (BA) of a single oral dose of either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet (NORVASC®) from Pfizer Inc. under fasting condition in male and female healthy subjects; and (2) to evaluate food effect on the PK profile of Levamlodipine Maleate Tablets from CSPC.', 'detailedDescription': 'This study consists of 2 parts:\n\nPart 1 will be a randomized, open-label, single-dose, two-way crossover study to assess the relative BA of levamlodipine maleate tablets from CSPC (Test) versus Amlodipine Besylate Tablet NORVASC® from Pfizer Inc. (Reference) after a single oral administration under fasted conditions in male and female healthy subjects. Approximately 32 healthy subjects will be enrolled in the US to obtain 27 completed subjects.\n\nPart 2 will be a single-arm, open-label, single-dose phase to assess food effect on the PK profile of levamlodipine maleate tablets from CSPC. Subjects who have completed Part 1 will be rolled over to Part 2 after a wash-out period for at least 14-days since the last dosing. Subjects will receive a single oral administration of study drug under a high-fat / high-calorie meal that should derive approximately 150, 250 and 500-600 calories from protein, carbohydrate and fat, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and be practicing a medically acceptable method of contraception with an annual failure rate of less than 1% during the study and 60 days after discontinuation of study treatment.\n2. Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;\n3. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;\n4. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg;\n\nExclusion Criteria:\n\n1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;\n2. Mean systolic blood pressure of three measurements \\>140 mmHg, or a mean diastolic blood pressure of three measurements \\>90 mmHg at screening.\n3. Known or suspected malignancy;\n4. Positive blood screen for human immunodeficiency virus (HIV), or hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);\n5. A history of seizure. However, a history of febrile seizure is allowed;\n6. Positive pregnancy test result, or plan to become pregnant if female;\n7. A hospital admission or major surgery within 30 days prior to screening;\n8. Participation in any other investigational drug trial within 30 days prior to screening;\n9. DSM-V substance use disorder within 6 months prior to screening;\n10. A positive result for alcohol or drugs of abuse at screening or admission;\n11. Tobacco use within 6 months prior to screening;\n12. An unwillingness or inability to comply with food and beverage restrictions during study participation;\n13. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;\n14. Use of prescription or over-the-counter (OTC) medications, and herbal medicines (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing;\n15. A history of suicide attempt in the past 12 months and/or seen by the investigator as having a significant history of risk of suicide or homicide;\n16. A history of intolerance or hypersensitivity to amlodipine or any excipients;\n17. An unwillingness of male participants to use appropriate contraceptive measures if engaging in sex intercourse with a female partner of childbearing potential during the study and 60 days after discontinuation of study treatment."}, 'identificationModule': {'nctId': 'NCT03657550', 'briefTitle': 'Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Conjupro Biotherapeutics, Inc.'}, 'officialTitle': 'Randomized Open-label Single-Dose Two-Way Crossover Study to Assess the Relative Bioavailability of 5mg Levamlodipine Tablet vs. 10mg Amlodipine Besylate Tablet in Healthy Subjects Followed by a Phase to Study Food Effect on the PK of Levamlodipine', 'orgStudyIdInfo': {'id': 'LAM-US-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Test Drug - Reference Product - Test Drug (Food Effect)', 'description': 'In Part 1, this group of subjects were treated with a single dose of 5 mg levamlodipine maleate tablets (Test Product), then crossed over to receive a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat/high-calorie meal to assess food effect.', 'interventionNames': ['Drug: Levamlodipine, Amlodipine', 'Drug: Amlodipine, Levamlodipine']}, {'type': 'OTHER', 'label': 'Reference Product - Test Drug - Test Drug (Food Effect)', 'description': 'In Part 1, this group of subjects were treated with a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product), and then crossed over to receive a single dose of 5 mg levamlodipine maleate tablets (Test Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat/high-calorie meal to assess food effect.', 'interventionNames': ['Drug: Levamlodipine, Amlodipine', 'Drug: Amlodipine, Levamlodipine']}], 'interventions': [{'name': 'Levamlodipine, Amlodipine', 'type': 'DRUG', 'otherNames': ['Xuanning®, NORVASC®'], 'description': 'In Part 1, this group of subjects were treated with a single dose of 5 mg levamlodipine maleate tablets (Test Product), then crossed over to receive a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat/high-calorie meal to assess food effect.', 'armGroupLabels': ['Reference Product - Test Drug - Test Drug (Food Effect)', 'Test Drug - Reference Product - Test Drug (Food Effect)']}, {'name': 'Amlodipine, Levamlodipine', 'type': 'DRUG', 'otherNames': ['NORVASC®, Xuanning®'], 'description': 'In Part 1, this group of subjects were treated with a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product), and then crossed over to receive a single dose of 5 mg levamlodipine maleate tablets (Test Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat/high-calorie meal to assess food effect.', 'armGroupLabels': ['Reference Product - Test Drug - Test Drug (Food Effect)', 'Test Drug - Reference Product - Test Drug (Food Effect)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, LLC', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}], 'overallOfficials': [{'name': 'Study Officials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Conjupro Biotherapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Conjupro Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CSPC Ouyi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}