Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: Oral salmon calcitonin, salmon calcitonin nasal spray (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Basel, Study Director, Affiliation: Novartis Basel +41 61 324 1111
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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: 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 mealPK 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
Eligibility
Minimum age: 40 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy postmenopausal women
Exclusion Criteria:
- Previous treatment with other osteoporosis medication
Other protocol defined inclusion/exclusion criteria may apply.
Locations and Contacts
Multiple Cities, Denmark
Additional Information
Starting date: October 2006
Last updated: May 25, 2007
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