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

A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Crossover Phase I Study Assessing Pharmacokinetics and Pharmacodynamics of Two Different SMC021 0.8 mg Variants and the Effect of Timing of Drug Intake in Healthy Postmenopausal Women

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00411125

Enrollment

Registered

2006-12-13

Start date

2006-08-31

Completion date

2006-11-30

Last updated

2006-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal, osteoporosis, Pharmacokinetics/dynamics, Calcitonin

Brief summary

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

Interventions

DRUGOral salmon calcitonin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 70 Years

Inclusion criteria

* Healthy postmenopausal women

Exclusion criteria

* Previous treatment with other osteoporosis medication Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic profile of the new variant compared to the current variant on Day 1	—
Effect on bone resorption biomarker on Day 1	—

Secondary

Measure	Time frame
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	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026