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

Novartis0 sites56 target enrollmentOctober 2006

ConditionsPostmenopausal Osteoporosis

DrugsOral salmon calcitonin, salmon calcitonin nasal spray

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Postmenopausal Osteoporosis
Sponsor: Novartis
Enrollment: 56
Primary Endpoint: 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
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Healthy postmenopausal women

Exclusion Criteria

•Previous treatment with other osteoporosis medication
•Other protocol defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

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 Outcomes

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