- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00395395
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
May 25, 2007 updated by: Novartis
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multiple Cities, Denmark
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy postmenopausal women
Exclusion Criteria:
- Previous treatment with other osteoporosis medication
Other protocol defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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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
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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
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PK profile of salmon calcitonin nasal spray
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Study Registration Dates
First Submitted
October 31, 2006
First Submitted That Met QC Criteria
October 31, 2006
First Posted (ESTIMATE)
November 2, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
May 28, 2007
Last Update Submitted That Met QC Criteria
May 25, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Osteoporosis, Postmenopausal
- Physiological Effects of Drugs
- Vasodilator Agents
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Calcitonin
- Salmon calcitonin
- Calcitonin Gene-Related Peptide
- Katacalcin
Other Study ID Numbers
- CSMC021A2112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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