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Bioequivalence Study in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387985
First Posted: October 13, 2006
Last Update Posted: July 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  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
Intervention Model: Crossover Assignment
Masking: None (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 Valeant Pharmaceuticals International, Inc.:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387985


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

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00387985     History of Changes
Other Study ID Numbers: 3200K1-103
First Submitted: October 11, 2006
First Posted: October 13, 2006
Last Update Posted: July 25, 2011
Last Verified: July 2011