To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers — CRC-C1721

Relative Bioavailability Clinical Trial

Official title:
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers

Status Completed

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

Relative Bioavailability

Clinical Trial Details

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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