- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00387985
Bioequivalence Study in Healthy Volunteers
November 21, 2019 updated by: Bausch Health Americas, Inc.
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
Primary: To determine the bioequivalence between the new formulation and the current formulation of the investigational drug, MOA-728.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Willingboro, New Jersey, United States, 08046
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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bioequivalence
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeff Cohn, Bausch Health Americas, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
October 11, 2006
First Submitted That Met QC Criteria
October 12, 2006
First Posted (Estimate)
October 13, 2006
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 21, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 3200K1-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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