drugset
drugset / Trial / NCT05303961

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

NCT05303961 ↗

Phase 1 Completed 56 enrolled Samjin Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start
2016-06-07
Primary completion
2016-11-11
Completion
2016-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic 240 mg Oral
Subject Pancrelipase Protein / enzyme biologic 360 mg Oral
Subject Pancrelipase Protein / enzyme biologic 480 mg Oral
Subject Pancrelipase Protein / enzyme biologic 720 mg Oral
Subject Pancrelipase Protein / enzyme biologic 1080 mg Oral
Subject Rebamipide Small molecule 200 mg Oral
Subject Rebamipide Small molecule 600 mg Oral

Indications

No indication recorded.