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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
This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 86 |
| Start date | 2006-08 |
| Completion | 2006-11 |
Conditions
- Postmenopausal Osteoporosis
Interventions
- Oral salmon calcitonin
Primary outcomes
- Pharmacokinetic profile of the new variant compared to the current variant on Day 1
- Effect on bone resorption biomarker on Day 1
Countries
Denmark