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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT00411125 (opens ClinicalTrials.gov in a new tab)Other idCSMC021A2111
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
86 participants
Sponsor
Novartis · Industry
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
Aug 2006
Primary completion
Not stated
Completion
Nov 2006
First posted
13 Dec 2006 (estimated)
Last update posted
13 Dec 2006 (estimated)
Conditions
Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007
  1. Ph 1

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

    NCT00411125

    Aug 2006 to Nov 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Oral salmon calcitoninDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes2

Outcomes the sponsor listed as primary.

  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(3)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

6 results

Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin.

Karsdal et al. 2008BMC clinical pharmacologycited by 40

PMID 19055791PMC2611964DOI 10.1186/1472-6904-8-12PUB-19055791

CC BY6 results
Download PDFSee results (6)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 40 Years up to 70 Years
Healthy volunteers
Not stated
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy postmenopausal women Exclusion Criteria: * Previous treatment with other osteoporosis medication Other protocol-defined inclusion/exclusion criteria may apply.

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