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AZD9056 formulation Phase III

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 23, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

AZD9056 formulation Phase III · 1 trial · 1 indication

Phase 1 1
NCT00908934AZD9056 Relative Bioavailability StudyHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
AZD9056 Relative Bioavailability Study
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Relative bioavailability of AZD9056 using PK variables Cmax and AUC
For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7

Secondary Endpoints

Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)
For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)
Frequent sampling occasions throughout the study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL50 or 400 mg AZD9056, Test formulation
2EXPERIMENTAL50 or 400 mg AZD9056, Reference formulation

Interventions

NameTypeDescription
AZD9056 formulation Phase III 50 mg (T)DRUGGiven as 50 mg tablet (T)
AZD9056 formulation Phase IIb 50 mg (R)DRUGGiven as 50 mg tablet (R)
AZD9056 formulation Phase III 200 mg (T)DRUGGiven as 400 mg (2 x 200 mg tablet (T))
AZD9056 formulation Phase IIb 200mg (R)DRUGGiven as 400 mg (2 x 200 mg tablet (R))
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of informed consent prior to any study-specific procedures * Healthy Volunteers, Females should not be of childbearing potential * BMI between 18 and 30 kg/m2 Exclusion Criteria: * Clinically significant ECG abnormality suggestive of underlying cardiovascular disea...

Countries:United Kingdom
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Frequently asked questions about AZD9056 formulation Phase III

What is AZD9056 formulation Phase III?

AZD9056 formulation Phase III is a small molecule drug being developed by AstraZeneca PLC. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and the therapeutic area is classified as Other. It is an investigational drug and has not been approved by regulatory authorities.

What is AZD9056 formulation Phase III used for?

AZD9056 formulation Phase III is being studied for use in healthy volunteers. The drug is in Phase 1 clinical development, and the current clinical trial is a relative bioavailability study. The drug is not approved for any medical condition and is still in the early stages of clinical investigation.

Who makes AZD9056 formulation Phase III?

AZD9056 formulation Phase III is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical development, and the company is conducting trials to evaluate its properties in healthy volunteers.

What phase is AZD9056 formulation Phase III in?

AZD9056 formulation Phase III is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. There is one completed Phase 1 trial, and no active trials are currently ongoing. The drug is being studied in healthy volunteers.

What clinical trials is AZD9056 formulation Phase III in?

AZD9056 formulation Phase III has one completed clinical trial, NCT00908934, titled 'AZD9056 Relative Bioavailability Study'. This Phase 1 trial enrolled 24 healthy volunteers in the United Kingdom. The study was controlled and randomized, and it has been completed. No active trials are currently listed.

Is AZD9056 formulation Phase III the same as AZD9056?

AZD9056 formulation Phase III is a specific formulation of the drug AZD9056, as indicated by its name. The drug is being developed by AstraZeneca PLC and is currently in Phase 1 clinical development. The clinical trial NCT00908934 is studying this formulation in healthy volunteers.