new trials in! ae they part of phase 3 hd?

HI all,

courtesy of tradesinc on YMB: go to link:


http://www.clinicaltrial.gov/ct2/results?term=pbt2&Search=Search

there's two new trials for PBT2 ( not in recruiting phase yet on clinicaltrials.gov site:

Trail 1:

Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2

Trail 2:

Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine


Condition:
Healthy Volunteers

Interventions:
Drug: Fed Cohort PBT2; Drug: Fasted Cohort PBT2



Are these part of phase 3 HD hurdles they must meet for FDA approval? anyone know

looks like they're getting busy