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

Novartis

Status and phase: Completed; Phase 1

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Oral salmon calcitonin, salmon calcitonin nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395395

CSMC021A2112

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy postmenopausal women

Exclusion criteria

• Previous treatment with other osteoporosis medication

Other protocol defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind