Bioequivalence Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00387985
First received: October 11, 2006
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

Primary: To determine the bioequivalence between the new formulation and the current formulation of the investigational drug, MOA-728.


Condition Intervention Phase
Healthy
Drug: MOA-728
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Single-dose, Randomized, 2-period Crossover, Bioequivalence Study Between the Current Formulation and the New Formulation of MOA-728 Administered Subcutaneously in Healthy Subjects

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • bioequivalence

Study Start Date: August 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387985

Locations
United States, New Jersey
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Jeff Cohn Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00387985     History of Changes
Other Study ID Numbers: 3200K1-103
Study First Received: October 11, 2006
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 14, 2014