Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-05 @ 5:34 PM
Study NCT ID:
NCT00532766
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
2007-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Pharmacokinetics and Pharmacodynamics of Jusline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061386', 'term': 'Insulin, Regular, Human'}], 'ancestors': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-24', 'studyFirstSubmitDate': '2007-09-19', 'studyFirstSubmitQcDate': '2007-09-19', 'lastUpdatePostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.', 'detailedDescription': 'To study the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration in the abdominal, and to compare this profile with Humulin insulin for three different preparations (Regular, NPH, and Premixed Regular/NPH (30/70)).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Non-diabetic\n* Age 18-35 year\n* Normal body mass index (BMI 18-25 kg/m2)\n\nExclusion Criteria:\n\n* Diabetics\n* Overweight/obese\n* Anemic, with liver, cardiac, renal or thyroid dysfunction'}, 'identificationModule': {'nctId': 'NCT00532766', 'briefTitle': 'Evaluating Pharmacokinetics and Pharmacodynamics of Jusline', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CMRC06-535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Jusline Humulin', 'interventionNames': ['Drug: Jusline']}], 'interventions': [{'name': 'Jusline', 'type': 'DRUG', 'otherNames': ['Humulin'], 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11461', 'city': 'Riyadh', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'University Diabetes Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Khalid A Al-Rubeaan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Medicine, King Saud University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}}}}