Recent Updates
Recently added Catalysts

Lansoprazole and AZD4635 solid formulation

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 28, 2011

Target and mechanism

ModalitySmall molecule

Also known as lansoprazole

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment149

FDA Designations

No designations recorded

Clinical trial landscape

Lansoprazole and AZD4635 solid formulation · 1 trial · 1 indication

Phase 1 1
NCT01147588Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of ClopidogrelHealthy
COMPLETED149 Analytics
PHASE1COMPLETED
Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel
Healthy
NCT01147588149
Unlock trial analytics

Study Endpoints

Primary Endpoints

Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA).
Baseline

Secondary Endpoints

Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the AUC, AUC 0-t and Cmax after the loading dose of clopidogrel (Day 1) and AUC 0-t, ss and Css, max.
Days 5,14, 29
Evaluate the safety and tolerability of clopidogrel given concomittantly with esomeprazole, omeprazole or lansoprazole by assessment of adverse events and calculation of change from baseline for clinical laboratory tests, vital signs and pECG.
Every in-house day
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALlansoprazole 60 mg + clopidogrel 300 mg/ 75 mg
2EXPERIMENTALomeprazole 80 mg + clopidogrel 300/75 mg
3EXPERIMENTALesomeprazole 40 mg + clopidogrel 300/75 mg
4EXPERIMENTALclopidogrel 300/75 mg alone

Interventions

NameTypeDescription
lansoprazoleDRUG60 mg (2x30-mg capsule), once daily
omeprazoleDRUG80 mg (2x40-mg capsule), once daily
esomeprazoleDRUG40 mg (1x40-mg capsule), once daily
clopidogrelDRUG300 mg loading dose on Day 1 then 75 mg daily for 28 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males within the age of 18-45 years and females within the age of 18-55 years with suitable veins for cannulation or repeated vein puncture. Females must be of non-childbearing potential. * Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive. * No cl...

Countries:United States
Unlock Eligibility Criteria