Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women

Novartis

Status and phase: Completed; Phase 1

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Oral salmon calcitonin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411125

CSMC021A2111

Details and patient eligibility

About

This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women

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