Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-29 @ 3:04 PM
Study NCT ID:
NCT00395395
Status:
COMPLETED
Last Update Posted:
2007-05-28
First Post:
2006-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028815', 'term': 'salmon calcitonin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-25', 'studyFirstSubmitDate': '2006-10-31', 'studyFirstSubmitQcDate': '2006-10-31', 'lastUpdatePostDateStruct': {'date': '2007-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal'}, {'measure': 'PK profile of the carrier of oral salmon calcitonin, taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal'}, {'measure': 'PK profile of salmon calcitonin nasal spray'}]}, 'conditionsModule': {'keywords': ['Postmenopausal', 'osteoporosis', 'Pharmacokinetics/dynamics', 'Calcitonin'], 'conditions': ['Postmenopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy postmenopausal women\n\nExclusion Criteria:\n\n* Previous treatment with other osteoporosis medication\n\nOther protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00395395', 'briefTitle': 'Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Partially-Blind, Randomized, Single-Dose, Placebo-Controlled Crossover Phase I Study Assessing the Effect of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of SMC021 0.8 mg in Healthy Postmenopausal Women', 'orgStudyIdInfo': {'id': 'CSMC021A2112'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oral salmon calcitonin, salmon calcitonin nasal spray', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Cities', 'country': 'Denmark'}], 'overallOfficials': [{'name': 'Novartis Basel', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Basel +41 61 324 1111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}