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A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women

NCT00620854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-02-01

Study results available
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Summary

This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).

Conditions

Interventions

DRUG

Recombinant Salmon Calcitonin (rsCT)

Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.

DRUG

Oral Tablet

0.15 mgs recombinant salmon calcitonin, single oral dose

DRUG

Oral Tablet

0.2mgs recombinant salmon calcitonin, single oral tablet

DRUG

Nasal Spray

200 IU recombinant salmon calcitonin, single intranasal spray

Sponsors & Collaborators

  • Tarsa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Legg, D.O. · Bio-Kinetic Clinical Applications, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00620854 on ClinicalTrials.gov