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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of SYHA1402 in Healthy Subjects

Diabetic Peripheral Neuropathy Clinical Trial

Official title:
Safety, Tolerability, Pharmacokinetics, and Food Effect of a Tablet Formulation of SYHA1402 in Healthy Subjects: A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study

Clinical Trial Summary

A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects.

Clinical Trial Description

This study consists of two parts: The objective of the food effect study (Part 1) is to investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed and fasted conditions following the oral administration of SYHA1402.

The primary objective of the multiple doses study (Part 2) is to investigate safety, tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral administration of Multiple rising doses.

Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral doses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04453618
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Yanping Liu
Phone 0311-67808817
Email liuyanping@mail.ecspc.com
Status Not yet recruiting
Phase Phase 1
Start date August 2020
Completion date December 2020
View Details
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