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

This study has been completed.

First Received: October 31, 2006 Last Updated: May 25, 2007 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00395395

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 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

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water Osteoporosis

Drug Information available for: Calcitonin human Calcitonin Fortical

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

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

Keywords provided by Novartis:

Postmenopausal
osteoporosis
Pharmacokinetics/dynamics
Calcitonin

Additional relevant MeSH terms:

Calcitonin
Vasodilator Agents
Physiological Effects of Drugs
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Cardiovascular Agents

Bone Diseases
Salmon calcitonin
Pharmacologic Actions
Calcitonin Gene-Related Peptide
Musculoskeletal Diseases
Therapeutic Uses
Osteoporosis, Postmenopausal

ClinicalTrials.gov processed this record on November 09, 2009