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Onglyza

Phase 1

Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 8, 2012

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
NCT01441869Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin ProducPHASE1 COMPLETED 28 — — Oct 1, 2011Dec 1, 2011Feb 8, 20121 United States
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Study Endpoints
Primary Endpoints
PK Saxagliptin: Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
At day 5 to day 6 at visit 2 or 3
PK : Metformin Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
At day 5 to day 6 at visit 2 or 3
Secondary Endpoints
PK : Saxagliptin 5-hydroxy Observed maximum concentration at steady state (Cmax,ss), time of maximum concentration (tmax,ss) at steady state, and area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
At day 5 to day 6 at visit 2 or 3
Safety will be assessed by the incidence, severity, and relatedness of adverse events.
From day -1 visit 2 until performed follow up ( Approximately 30 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet
BEXPERIMENTAL5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet
CEXPERIMENTAL5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet
DEXPERIMENTAL5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet
Interventions
NameTypeDescription
Onglyza (saxagliptin)DRUGOral tablets, 5 mg , single dose
DiabexDRUGExtended release oral tablets, 1000 mg, single dose
5-mg saxagliptin/1000 mg metforminDRUGExtended release fixed dose combination tablet, single dose
5-mg saxagliptin/500 mg metforminDRUGExtended release fixed dose combination tablet, single dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated informed consent prior to any study specific procedures * Males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive * Females must have a negative urine preg...

Countries:United States
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