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D961S

Phase 1

Bioequivalence Study | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 9, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01494402Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male SubjectsPHASE1 COMPLETED 77 — — Jan 1, 2012Mar 1, 2012Apr 9, 20121 Japan
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Study Endpoints
Primary Endpoints
Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).
Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6

All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.

Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)
Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6

All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.

Secondary Endpoints
Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA
Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6
Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature.
Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
D961SEXPERIMENTAL2 way crossover
esomeprazole + buffered acetylsalicylic acidEXPERIMENTAL2 way crossover
Interventions
NameTypeDescription
D961SDRUGOral gelatine capsule
EsomeprazoleDRUGOral HPMC capsule
Buffered acetylsalicylic acidDRUGTablet
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese males 20-45 years of age * Classified as homo-EM * Negative for HIV, Hepatitis B, Hepatitis C and syphilis * Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) * Body weight 50-85 kg Exclusion Criteria: * Significant clinical illness from 2 weeks preceding t...

Countries:Japan
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