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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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00395395
First received: October 31, 2006
Last updated: May 25, 2007
Last verified: May 2007
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395395

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

No publications provided

ClinicalTrials.gov Identifier: NCT00395395     History of Changes
Other Study ID Numbers: CSMC021A2112
Study First Received: October 31, 2006
Last Updated: May 25, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Novartis:
Postmenopausal
osteoporosis
Pharmacokinetics/dynamics
Calcitonin

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

ClinicalTrials.gov processed this record on May 16, 2013