MedTrace Logo

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

NCT05303961 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

SA001 240mg + Rebamipide 200mg or Placebo

Cohort 1 in the Part1(Single dose): Study drug(SA001 240mg + Rebamipide 200mg), Comparator: Placebo

DRUG

SA001 480mg or Placebo

Cohort 2 in the Part1(Single dose): Study drug(SA001 480mg), Comparator(Placebo)

DRUG

SA001 710mg + Rebamipide 600mg or Placebo

Cohort 3 in the Part1(Single dose): Study drug(SA001 720mg + Rebamipide 600mg), Comparator(Placebo)

DRUG

SA001 1,080mg or Placebo

Cohort 4 in the Part1(Single dose): Study drug(SA001 1,080mg), Comparator(Placebo)

DRUG

SA001 360mg or Placebo

Cohort 5 in the Part2(Multiple dose): Study drug(SA001 360mg), Comparator(Placebo)

DRUG

SA001 720mg or Placebo

Cohort 6 in the Part2(Multiple dose): Study drug(SA001 720mg), Comparator(Placebo)

DRUG

SA001 1,080mg or Placebo

Cohort 7 in the Part2(Multiple dose): Study drug(SA001 1,080mg), Comparator(Placebo)

Sponsors & Collaborators

  • Samjin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303961 on ClinicalTrials.gov