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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

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Onglyza · 1 trial · 1 indication

Phase 1 1
NCT01441869Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin ProducBioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin
COMPLETED28 Analytics
PHASE1COMPLETED
Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc
Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin
NCT0144186928
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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 to 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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Frequently asked questions about Onglyza

What is Onglyza used for?

Onglyza is a small molecule drug being studied for bioequivalence, specifically to compare log-transformed AUCss and Cmax,ss values for saxagliptin and metformin. It is an investigational drug in clinical development, and its use in this context is being evaluated in a Phase 1 clinical trial.

Who makes Onglyza?

Onglyza is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this drug to evaluate its properties in a controlled study setting.

What phase is Onglyza in?

Onglyza is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its effects. The current Phase 1 trial has been completed.

What clinical trials is Onglyza in?

Onglyza has one completed Phase 1 clinical trial, identified as NCT01441869. This study, titled "Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc", enrolled 28 healthy volunteers in the United States.

Is Onglyza the same as saxagliptin and metformin?

Onglyza is being studied in combination with metformin, as the trial measures blood levels of both saxagliptin and metformin after dosing. The drug is not the same as these components; rather, it is a product containing saxagliptin and metformin, and the study evaluates their bioequivalence.