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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00395395 |
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.
Condition | Intervention | Phase |
---|---|---|
Postmenopausal Osteoporosis |
Drug: Oral salmon calcitonin, salmon calcitonin nasal spray |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | 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 |
Estimated Enrollment: | 56 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CSMC021A2112 |
Study First Received: | October 31, 2006 |
Last Updated: | May 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00395395 |
Health Authority: | Denmark: Danish Medicines Agency |
Postmenopausal osteoporosis Pharmacokinetics/dynamics Calcitonin |
Calcitonin Gene-Related Peptide Calcitonin Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis |
Bone Diseases, Metabolic Healthy Salmon calcitonin Bone Diseases |
Vasodilator Agents Therapeutic Uses Physiological Effects of Drugs |
Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |