Status:
COMPLETED
Palifermin DDI (Drug Drug Interaction)
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if Paliferim interacts with Heparin.
Detailed Description
Heparin has been shown to modulate binding of palifermin to the KGF receptor. Therefore, as part of a post-marketing regulatory commitment with the Food and Drug Administration (FDA), the purpose of t...
Eligibility Criteria
Inclusion
- Inclusion: Baseline aPTT values for all subjects must be within normal range. In addition, all subjects must also test negative for occult blood in the stool, have no history of bleeding disorders or no use of aspirin or NSAIDs within 14 days of study Day 1.
Exclusion
- Exclusion: The study will also exclude subjects who have any evidence or history of thrombocytopenia, heparin-induced thrombocytopenia or other contraindications to heparin (e.g., recent surgeries).
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00361348
Start Date
December 1 2005
End Date
July 1 2006
Last Update
November 6 2014
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