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over-encapsulated oseltamivir

Phase 1

Influenza, Human | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 7, 2017

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01258530A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy VolunteersPHASE1 COMPLETED 28 — — Dec 20, 2010Feb 3, 2011Jun 7, 20171 United States
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Study Endpoints
Primary Endpoints
Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity))
9 days
Plasma oseltamivir carboxylate maximum observed concentration (Cmax)
9 days
Secondary Endpoints
Plasma oseltamivir carboxylate area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC(0-t))
9 days
Plasma oseltamivir carboxylate terminal phase half-life (t1/2)
9 days
Plasma oseltamivir carboxylate time of occurrence of Cmax (tmax)
9 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALOver-encapsulated oseltamivir 75 mg (1 capsule)
Treatment BEXPERIMENTALoseltamivir 75 mg (1 capsule)
Interventions
NameTypeDescription
over-encapsulated oseltamivirDRUG75 mg once
oseltamivirDRUG75 mg once
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation...

Countries:United States
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