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Sulfatinib T

Phase 1

Relative Bioavailability | Small molecule | Other |HUTCHMED (China) Limited|Last Updated: Nov 13, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Sulfatinib T · 1 trial · 1 indication

Phase 1 1
NCT03483259To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different ManufacturersRelative Bioavailability
COMPLETED30 Analytics
PHASE1COMPLETED
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers
Relative BioavailabilityUnlock trial analytics

Study Endpoints

Primary Endpoints

The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.

Maximum observed plasma concentration (Cmax) of Sulfatinib
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

Maximum observed concentration, occurring at Tmax.

The time to Cmax (peak time, Tmax) of Sulfatinib
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

The time at which maximum plasma concentration (Cmax) is observed.

Half-life (t1/2) of Sulfatinib
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

The time required for the concentration of the drug to reach half of its original value.

Relative Bioavailability
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

This term represents the relationship between the bioavailability of a substance in two different media.

Secondary Endpoints

Adverse Event (AE) monitoring of Sulfatinib
Measured from the date signed ICF to within 14 days after the last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A-Sulfatinib T capsuleEXPERIMENTALThe subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.
Arm B-Sulfatinib R capsuleEXPERIMENTALThe subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd.

Interventions

NameTypeDescription
Sulfatinib T capsuleDRUGSulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
Sulfatinib R capsuleDRUGSulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol; 2. Age of 18-40 (inclusive), male healthy volunteers; 3. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as norm...

Countries:China
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Frequently asked questions about Sulfatinib T

What is Sulfatinib T used for?

Sulfatinib T is an investigational small molecule being studied for its relative bioavailability. It is being evaluated in a clinical trial to explore the pharmacokinetics and relative bioavailability of Sulfatinib capsules from two different manufacturers. The drug is in Phase 1 clinical development.

Who makes Sulfatinib T?

Sulfatinib T is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical research on this investigational small molecule drug.

What phase is Sulfatinib T in?

Sulfatinib T 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 evaluate its pharmacokinetics and relative bioavailability.

What clinical trials is Sulfatinib T in?

Sulfatinib T is associated with one completed clinical trial, NCT03483259, titled 'To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers.' This Phase 1 study enrolled 30 male participants in China and was controlled but not double-blinded.

Is Sulfatinib T the same as Sulfatinib?

Sulfatinib T is a designation for the drug Sulfatinib, which is being studied in capsule form. The clinical trial NCT03483259 evaluates the relative bioavailability of Sulfatinib capsules from two different manufacturers, indicating that Sulfatinib T refers to this specific formulation or study context.