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Study to Compare Pharmacokinetic Property of SYO-1644 Tab. and Nexavar Tab. in Healthy Male Volunteers

NCT03674060 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-08-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics characteristics ,tolerability, and safety after orally administrating SYO-1644 to healthy male volunteers in randomized, active-controlled, open-label clinical study.

Conditions

  • Healthy, Male

Interventions

DRUG

SYO-1644

100mg: SYO-1644 tablet, PO, 1 100mg tablet 150mg: SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet 200mg: SYO-1644 tablet, PO, 2 100mg tablet

DRUG

Nexavar tab

Nexavar 200mg/tablet, PO, 1 tablet

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Samyang Biopharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, MD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-28
Primary Completion
2019-02-08
Completion
2019-07-23

Countries

  • South Korea

Study Locations

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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 NCT03674060 on ClinicalTrials.gov