Postmenopausal Osteoporosis Clinical Trial
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
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 |
Verified date | May 2007 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Denmark,
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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