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Study of DWJ1351 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02665832
Recruitment Status : Unknown
Verified January 2016 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: DWJ1351 Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers
Study Start Date : January 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: AB
Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351
Drug: DWJ1351
Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
Experimental: BA
DWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
Drug: DWJ1351
Drug: Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)

Primary Outcome Measures :
  1. AUC [ Time Frame: 0 - 144 hr ]
  2. Cmax [ Time Frame: 0 - 144 hr ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02665832

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Contact: Sang-Joon Kim +82 550 8708

Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
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Responsible Party: Daewoong Pharmaceutical Co. LTD. Identifier: NCT02665832    
Other Study ID Numbers: DW_DWJ1351002
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists