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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00421590 |
This study will assess the effect of concomitant antacid on the pharmacokinetics and pharmacodynamics of SMC021
Condition | Intervention | Phase |
---|---|---|
Health Postmenopausal Women |
Drug: SMC021 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Randomized, Partially Blind, Placebo Controlled, Crossover, Single Oral Dose Study to Assess the Effect of Concomitant Antacid (Calcium Carbonate / Magnesium Hydroxide) on the Pharmacokinetics and Pharmacodynamics of SMC021 (0.8 mg Salmon Calcitonin/200 mg 5-CNAC) in Healthy Postmenopausal Women |
Estimated Enrollment: | 38 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study ID Numbers: | CSMC021C2208 |
Study First Received: | January 11, 2007 |
Last Updated: | June 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00421590 |
Health Authority: | Denmark: Danish Medicines Agency |
Randomized, partially blind, placebo controlled, crossover, drug interaction with concomitant antacid, pharmacokinetics, pharmacodynamics, SMC021 |
Calcitonin Gene-Related Peptide Calcitonin Calcium, Dietary Magnesium Hydroxide |
Calcium Carbonate Healthy Salmon calcitonin |
Molecular Mechanisms of Pharmacological Action Antacids Pharmacologic Actions |