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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00395395
Other study ID # CSMC021A2112
Secondary ID
Status Completed
Phase Phase 1
First received October 31, 2006
Last updated May 25, 2007
Start date October 2006

Study information

Verified date May 2007
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date
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


Intervention

Drug:
Oral salmon calcitonin, salmon calcitonin nasal spray


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 (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 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
Secondary 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
Secondary PK profile of salmon calcitonin nasal spray
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