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To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers

NCT05433844 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-03-21

No results posted yet for this study

Summary

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Conditions

  • Healthy

Interventions

DRUG

Reference Drug or Test Drug

Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration

Sponsors & Collaborators

Principal Investigators

  • SeungHwan Lee, PI · Clinical Trial Center, Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-02
Primary Completion
2022-08-26
Completion
2022-09-14

Countries

  • South Korea

Study Locations

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Entities

Companies

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 NCT05433844 on ClinicalTrials.gov