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Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

Healthy Clinical Trial

Official title:
A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of SA001 After Oral Administration in Healthy Male Subjects

Clinical Trial Summary

This study consists of Part 1 followed Part 2. Part 1 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and active comparator(Rebamipide) in healthy male volunteers. Part 2 The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of multiple oral dose of SA001 in healthy male volunteers.

Clinical Trial Description

Part 1(Single dose, dose escalation study, SA001 240mg~1,080mg dose group) The starting dose is SA001 240mg, and the maximum dose is 1,080mg. Each dose group is assigned to Experimental group (SA001 or SA001 + Active Comparator(Rebamipide)) or Placebo group in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a single oral administration. Part 2 (Multiple dose, dose escalation study, SA001 360mg~1,080mg dose group) The starting dose is SA001 360mg, and the maximum dose is 1,080mg. Each dose group is assigned to SA001 or Placebo in a ratio of 3:1. The pharmacokinetics, safety and tolerability of SA001 and its metabolite are investigated after a multiple oral administration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05303961
Study type Interventional
Source Samjin Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 7, 2016
Completion date November 11, 2016
View Details
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