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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00395395
First Posted: November 2, 2006
Last Update Posted: May 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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
  • 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
  • PK profile of salmon calcitonin nasal spray

Estimated Enrollment: 56
Study Start Date: October 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
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.

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

ClinicalTrials.gov Identifier: NCT00395395     History of Changes
Other Study ID Numbers: CSMC021A2112
First Submitted: October 31, 2006
First Posted: November 2, 2006
Last Update Posted: May 28, 2007
Last Verified: May 2007

Keywords provided by Novartis:
Postmenopausal
osteoporosis
Pharmacokinetics/dynamics
Calcitonin

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasodilator Agents