Oral Heparin: Status
Submitted PROTECT Phase III trial results to FDA
- Bridge of data from liquid to solid (seek comparable activity)
Multiple arm single-dose Phase I study underway (Europe)
- Study in healthy male volunteers
- Assessing safety and tolerability of different formulations; measuring APTT
- Dose based on previous solid dose study (12/02)
Evaluating oral LMWH vs. placebo