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Trial record 20 of 231 for:    CALCITONIN SALMON

Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00395395
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : May 28, 2007
Sponsor:
Information provided by:
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Oral salmon calcitonin, salmon calcitonin nasal spray Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : October 2006

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Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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
  2. 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
  3. PK profile of salmon calcitonin nasal spray


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Healthy postmenopausal women

Exclusion Criteria:

  • Previous treatment with other osteoporosis medication

Other protocol defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395395


Locations
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Denmark
Multiple Cities, Denmark
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Basel Novartis Basel +41 61 324 1111

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ClinicalTrials.gov Identifier: NCT00395395     History of Changes
Other Study ID Numbers: CSMC021A2112
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: May 28, 2007
Last Verified: May 2007
Keywords provided by Novartis:
Postmenopausal
osteoporosis
Pharmacokinetics/dynamics
Calcitonin
Additional relevant MeSH terms:
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Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents