Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT03199261
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2017-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-23'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalency between the 2 formulations of rE-4', 'timeFrame': 'before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection', 'description': 'Area under curve'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.', 'detailedDescription': 'The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects will receive a subcutaneous single dose of rE-4 (rE-4 Injection 10µg or rE-4 Freeze-dried Powder 10µg) administered 30min prior to the start time of a standard breakfast.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male adult volunteers of 18-45 years old, who can be inserted needle.\n* Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/\\[height(m)\\]2，During Screening period body weight≥50 kg.\n* Subjects are fully informed and voluntarily consent to participate in this study.\n\nExclusion Criteria:\n\n* A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.\n* History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.\n* History or presence neurological disorder disease.\n* Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.\n* Participation in a clinical drug study 30 days prior to present study.\n* FPG≥6.1mmol/L or \\<3.9mmol/L.\n* SBP\\<90mmHg or \\>140mmHg; DBP\\>90mmHg.\n* Use of any other drugs,vitamine and mineral substance.\n* Blood donation more than 200 mL blood within 3 months prior to the study.\n* Smoker (\\>5 cigarettes/day) or alcoholist (355 ml alcohol/day).\n* History or Family history of hypoglycemia.\n* History of allergy or hypersensitivity.\n* Subjects planning to give birth or donate sperm during the study or within 3 months after the study.\n* Other unfavorable factors diagnosed by investigators.'}, 'identificationModule': {'nctId': 'NCT03199261', 'briefTitle': 'A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'SN-YQ-2016018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rE-4 Injection', 'description': '10µg, rE-4 Injection, 30 minutes prior to the start time of a standard breakfast.', 'interventionNames': ['Drug: rE-4 Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rE-4 Freeze-dried Powder', 'description': '10µg, rE-4 Freeze-dried Powder, 30 minutes prior to the start time of a standard breakfast.', 'interventionNames': ['Drug: rE-4 Freeze-dried Powder']}], 'interventions': [{'name': 'rE-4 Injection', 'type': 'DRUG', 'otherNames': ['Recombinant Exendin-4 Injection'], 'description': 'During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Injection 10µg administered 30 minutes prior to the start time of a standard breakfast.', 'armGroupLabels': ['rE-4 Injection']}, {'name': 'rE-4 Freeze-dried Powder', 'type': 'DRUG', 'otherNames': ['Recombinant Exendin-4 Freeze-dried Powder'], 'description': 'During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Freeze-dried Powder 10µg administered 30 minutes prior to the start time of a standard breakfast.', 'armGroupLabels': ['rE-4 Freeze-dried Powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'country': 'China', 'facility': 'The Affiliated Hospital Military Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Hengyan Qu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital Military Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}