Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200031, China
NCT Number: NCT03483259
This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.
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Notify Me18 year–40 year
Male
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200031, China
27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
Other names: HMPL-012, Surufatinib
Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
Other names: HMPL-012, Surufatinib
Time frame: 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.
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Maximum observed concentration, occurring at Tmax.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured from the date signed ICF to within 14 days after the last dose
AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters.
Hutchison Medipharma Limited
Industry
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers
Acronym: CRC-C1721
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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