drugset
drugset / Trial / NCT02470286

A Phase 1 Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

NCT02470286 ↗

Phase 1 Completed 40 enrolled Samjin Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindOther

Summary

The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and its active metabolite in healthy male volunteers.

Timeline

Start
2015-06-29
Primary completion
2015-09-18
Completion
2015-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic 60 mg Oral
Subject Pancrelipase Protein / enzyme biologic 120 mg Oral
Subject Pancrelipase Protein / enzyme biologic 180 mg Oral
Subject Pancrelipase Protein / enzyme biologic 240 mg Oral
Subject Pancrelipase Protein / enzyme biologic 300 mg Oral

Indications

No indication recorded.