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Fospropofol disodium

Phase 1

Drug Safety | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Jan 6, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01271569A Study to Assess the Efficacy and Safety of Fospropofol DisodiumPHASE1 COMPLETED 80Mar 1, 2010Jan 1, 2011Jan 6, 20111 China
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Study Endpoints
Primary Endpoints
BIS
2hr after administration
Secondary Endpoints
Modified OAA/S Score
2hr after administration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
In the treatment armOTHER -
Interventions
NameTypeDescription
Fospropofol disodiumDRUGFospropofol disodium: 0.5g
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to fo...

Countries:China
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