drugset / Trial / NCT03249753

The Effect of Food Intake on the Pharmacokinetic of Single Dose SPH3127 Tablets in Chinese Health Subjects

NCT03249753

Phase 1 Completed 20 enrolled Shanghai Pharmaceuticals Holding Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-09-23
Primary completion
2018-09-30
Completion
2018-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject sitokiren Small molecule 200 mg

Indications