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salmon calcitonin

Phase 1

Postmenopausal Osteoporosis | Small molecule | Endocrine |Novartis AG|Last Updated: Dec 13, 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

salmon calcitonin · 1 trial · 1 indication

Phase 1 1
NCT00411125Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal WomenPostmenopausal Osteoporosis
COMPLETED86 Analytics
PHASE1COMPLETED
Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Postmenopausal OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Oral salmon calcitoninDRUG -
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Eligibility Criteria

Age Range40 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

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

Countries:Denmark
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Frequently asked questions about salmon calcitonin

What is salmon calcitonin used for?

Salmon calcitonin is being studied for use in postmenopausal osteoporosis. It is an investigational small molecule in Phase 1 clinical development, evaluated in healthy postmenopausal women to understand its pharmacokinetics and pharmacodynamics. The drug is not approved and remains in clinical testing.

Who makes salmon calcitonin?

Salmon calcitonin is being developed by Novartis AG, traded on the New York Stock Exchange under the ticker NVS. The company is conducting clinical research on this investigational drug for postmenopausal osteoporosis.

What phase is salmon calcitonin in?

Salmon calcitonin is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for postmenopausal osteoporosis. The Phase 1 trial has been completed.

What clinical trials is salmon calcitonin in?

Salmon calcitonin has one completed Phase 1 trial, NCT00411125, titled 'Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women.' The trial enrolled 86 female participants aged 40 years and older in Denmark.

Is salmon calcitonin a randomized controlled trial drug?

The Phase 1 trial of salmon calcitonin was randomized and double-blind, but it had an uncontrolled design, meaning there was no control group. The study was completed and enrolled 86 postmenopausal women.