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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DWC201903; Drug: DWJ1421

Study type: Interventional

Funder types: Industry

Identifiers

NCT04278391

DW_DWJ1421101

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

A (RT)

Experimental group

Description:

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

Treatment:

Drug: DWC201903

B (TR)

Experimental group

Description:

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

Treatment:

Drug: DWJ1421