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Sorbitol+Phenylephrine

Phase 1

Acute Pain | Small molecule | Pain |BioLineRx Ltd.|Last Updated: Apr 15, 2008

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00374881A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human SubjectsPHASE1 COMPLETED 9Sep 1, 2006Aug 1, 2007Apr 15, 20082 Israel
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Study Endpoints
Primary Endpoints
Safety
8 hours
Secondary Endpoints
Efficacy
4 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORMorphine High Dose
2PLACEBO_COMPARATORMorphine Low Dose
3PLACEBO_COMPARATORSorbitol Phenylephrine
4EXPERIMENTALSorbitol high concentration+Phenylephrine+Morphine
5EXPERIMENTALSorbitol low concentration+Phenylephrine+Morphine
Interventions
NameTypeDescription
MorphineDRUGMorphine
Sorbitol+PhenylephrineDRUGSorbitol+Phenylephrine
Sorbitol+Phenylephrine+MorphineDRUGSorbitol+Phenylephrine+Morphine
Sorbitol low concentration+Phenylephrine+MorphineDRUGSorbitol low concentration+Phenylephrine+Morphine
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Ability to provide written informed consent * Healthy male or female between 18 and 40 years of age, inclusive. * Women have to test negative for pregnancy. * Body weight within 15% of ideal body weight based on Metropolitan Life assurance tables. * No concomitant medications ...

Countries:Israel
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