Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-02

Study Completion Date

2020-02-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152

NCT02502721

Healthy

COMPLETED PHASE1

Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers

NCT02369302

Healthy

COMPLETED PHASE1

Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects

NCT05812404

Drug Drug Interaction

UNKNOWN PHASE1

A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects

NCT07027982

Healthy Adults

COMPLETED PHASE1

An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers

NCT05832697

Healthy Subject

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A (RT)

Period 1 : Reference drug (DWC201903) Period 2 : Test durg(DWJ1421)

Group Type EXPERIMENTAL

DWC201903

Intervention Type DRUG

1 tablet administered in fasting condition

B (TR)

Period 1 : Test durg(DWJ1421) Period 2 : Reference drug (DWC201903)

Group Type EXPERIMENTAL

DWJ1421

Intervention Type DRUG

1 tablet administered in fasting condition

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DWJ1421

1 tablet administered in fasting condition

Intervention Type DRUG

DWC201903

1 tablet administered in fasting condition

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Between 19 aged and 45 aged in healthy male adult
* Body weight more than 50kg
* Body Mass Index more than 18.0 and under 27.0

Exclusion Criteria

* Those who have clinical significant liver, kidney, digestive system, respiratory, endocrine, nervous system, hematology and oncology, cardiovascular, urinary diseae or past history
* Those who have a gastrointestinal disease history that can effect drug absorption or surgery
* Those who have hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes