Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women

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

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.

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: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

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 meal

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

PK profile of salmon calcitonin nasal spray

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.

Multiple Cities, Denmark

Starting date: October 2006
Last updated: May 25, 2007