Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

Daewoong Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)

Drug: Sevikar and Crestor

Study type

Interventional

Funder types

Industry

Identifiers

NCT03753477

DW_DWJ1351004

Details and patient eligibility

About

The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers

Full description

The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers.

Enrollment

64 patients

Sex

Male

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject who provided written informed consent to participate in this study
Healthy adult male subjects aged 19 to 50 years
Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2
Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results

Exclusion criteria

Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
Subjects who had a serious clinical illness that can impact fate of drugs absorption
Subject who shows vital signs with the number of systolic blood pressure of >140 mmHg or <100 mmHg, and the number of diastolic blood pressure of >90mmHg or <65mmHg
Subject who have experienced drug abuse
Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month)
Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication