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triazolam liquid

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Oct 24, 2016

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01421043A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy SubjectsPHASE1 COMPLETED 34 — — Sep 1, 2011Oct 1, 2011Oct 24, 20161 Belgium
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Study Endpoints
Primary Endpoints
Area Under the Curve (AUC) to last time point (t)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Maximum concentration of drug (Cmax)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Secondary Endpoints
Area Under the Curve (AUC) to time infinity (inf) (if data permit)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Area Under the Curve (AUC) percent extrapolated (%exp)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Half-life (if data permit)
0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
triazolam liquid oral dropsEXPERIMENTAL -
triazolam tabletsACTIVE_COMPARATOR -
Interventions
NameTypeDescription
triazolam liquid oral dropsDRUG0.25 mg single dose oral drops
triazolam tabletsDRUG0.25 mg single oral dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG ...

Countries:Belgium
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