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Clinical Trial Summary

This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03483259
Study type Interventional
Source Hutchison Medipharma Limited
Contact
Status Completed
Phase Phase 1
Start date April 2, 2018
Completion date May 18, 2018

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