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NCT00411125 Clinical Trial

Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

Postmenopausal Osteoporosis Clinical Trial

Official title:
A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Crossover Phase I Study Assessing Pharmacokinetics and Pharmacodynamics of Two Different SMC021 0.8 mg Variants and the Effect of Timing of Drug Intake in Healthy Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00411125
Other study ID # CSMC021A2111
Secondary ID
Status Completed
Phase Phase 1
First received December 11, 2006
Last updated December 11, 2006
Start date August 2006
Est. completion date November 2006

Study information
Verified date December 2006
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Healthy postmenopausal women

Exclusion Criteria:

- Previous treatment with other osteoporosis medication

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oral salmon calcitonin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic profile of the new variant compared to the current variant on Day 1
Primary Effect on bone resorption biomarker on Day 1
Secondary Effect on bone resorption biomarker 24 hours after the last dosing on Day 3
Secondary Effect on bone resorption biomarker after drug intake at different timepoints
Secondary Effect of dosing at different timepoints on the pharmacokinetic profile
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