Bioequivalence Study in Healthy Volunteers
Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00387985
Collaborator
(none)
1
1
Study Details
Study Description
Brief Summary
Primary: To determine the bioequivalence between the new formulation and the current formulation of the investigational drug, MOA-728.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
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
Study Start Date
:
Aug 1, 2006
Actual Primary Completion Date
:
Sep 1, 2006
Actual Study Completion Date
:
Sep 1, 2006
Outcome Measures
Primary Outcome Measures
- bioequivalence []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Willingboro | New Jersey | United States | 08046 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Jeff Cohn, Bausch Health Americas, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00387985
Other Study ID Numbers:
- 3200K1-103
First Posted:
Oct 13, 2006
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019