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Completed

NCT Number: NCT00411125

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

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

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Copenhagen, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy postmenopausal women

Exclusion criteria

  • Previous treatment with other osteoporosis medication

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Oral salmon calcitonin

Drug

Primary outcomes

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

  2. Effect on bone resorption biomarker on Day 1

Secondary outcomes

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

  2. Effect on bone resorption biomarker after drug intake at different timepoints

  3. Effect of dosing at different timepoints on the pharmacokinetic profile

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
Dec 13, 2006
Registry last updated
Dec 13, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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