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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DWC20141, DWC20142; Drug: DWC20141; Drug: DWC20142

Study type: Interventional

Funder types: Industry

Identifiers

NCT02369302

DW_DWJ1367001

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.

Enrollment: 30 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult male volunteers aged 19 to 45 years
2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion criteria

1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.

2. A subject who shows the following result in clinical laboratory test

   • AST, ALT > 1.25 times of the upper limit of normal range
   • PR ≥ 210 msec
   • QRS ≥ 120 msec
   • QT ≥ 500 msec
   • QTcF ≥ 500 msec

3. Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.

Trial design

30 participants in 3 patient groups

DWC20141

Experimental group

Description:

multiple dose of DWC20141

Treatment:

Drug: DWC20141

DWC20142

Experimental group

Description:

multiple dose of DWC20142

Treatment:

Drug: DWC20142

DWC20141+DWC20142

Experimental group

Description:

multiple dose of DWC20141 and DWC20142

Treatment:

Drug: DWC20141, DWC20142