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NCT number NCT03249753
Study type Interventional
Source Shanghai Pharmaceuticals Holding Co., Ltd
Contact yang lin
Phone 13701073623
Email linyang3623@163.com
Status Recruiting
Phase Phase 1
Start date September 23, 2017
Completion date September 30, 2018

Clinical Trial Summary

This study is a single-center, randomized, open, double-cycle and double-cross and self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on pharmacokinetics of SPH3127 tablets.

Two panels, each consisting of ten participants (The number of single-sex subjects is not less than 1/3 of the total number) will be randomized to A or B groups.


Clinical Trial Description

Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.

Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.


Study Design


Related Conditions & MeSH terms


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