Study of DWJ1351 in Healthy Male Volunteers

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin); Drug: DWJ1351

Study type: Interventional

Funder types: Industry

Identifiers

NCT02665832

DW_DWJ1351002

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

Enrollment: 58 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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
• Subject who provided written informed consent to participate in this study

Exclusion criteria

• Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
• Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease
• 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 ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

AB

Experimental group

Description:

Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351

Treatment:

Drug: DWJ1351

Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

BA

Experimental group

Description:

DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

Treatment:

Drug: DWJ1351

Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)