Study of DWJ1351 in Healthy Male Volunteers

NCT ID: NCT02665832

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

AB

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

Group Type: EXPERIMENTAL

DWJ1351

Intervention Type: DRUG

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

Intervention Type: DRUG

BA

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

Group Type: EXPERIMENTAL

DWJ1351

Intervention Type: DRUG

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

Intervention Type: DRUG

Interventions

DWJ1351

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sang-Joon Kim

Role: CONTACT

sjkim050@daewoong.co.kr

+82 550 8708

Other Identifiers

DW_DWJ1351002

Identifier Type: -

Identifier Source: org_study_id