NCT00387985

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

October 11, 2006

Last Update Submit

November 21, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • bioequivalence

Interventions

MOA-728DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Willingboro, New Jersey, 08046, United States

Location

Study Officials

  • Jeff Cohn

    Bausch Health Americas, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 13, 2006

Study Start

August 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations

US(1)