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Trial · Interventional

CompletedPhase 1Registry data

Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women

NCTNCT00395395 (opens ClinicalTrials.gov in a new tab)Other idCSMC021A2112
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
56 participants (estimated)
Sponsor
Novartis · Industry
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
Oct 2006
Primary completion
Not stated
Completion
Not stated
First posted
2 Nov 2006 (estimated)
Last update posted
28 May 2007 (estimated)
Conditions
Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed

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

    Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women

    NCT00395395

    Start Oct 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 the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.

Interventions

  • Oral salmon calcitonin, salmon calcitonin nasal sprayDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal

Secondary outcomes(3)

  1. Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal

  2. PK profile of the carrier of oral salmon calcitonin, taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal

  3. PK profile of salmon calcitonin nasal spray

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

Studies0

Studies that cite this trial.

No study cites this trial.

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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