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

Novartis86 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postmenopausal Osteoporosis

Interventions

Oral salmon calcitoninDRUG

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy postmenopausal women Exclusion Criteria: * Previous treatment with other osteoporosis medication Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Unnamed facility

Copenhagen, Denmark

Outcomes

Primary Outcomes

Pharmacokinetic profile of the new variant compared to the current variant on Day 1

Effect on bone resorption biomarker on Day 1

Secondary Outcomes

Effect on bone resorption biomarker 24 hours after the last dosing on Day 3

Effect on bone resorption biomarker after drug intake at different timepoints

Effect of dosing at different timepoints on the pharmacokinetic profile

Data from ClinicalTrials.gov

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