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 on October 31, 2006. Last Updated on 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:	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:

MedlinePlus related topics: 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

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 February 12, 2012