Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin); Drug: Sevikar and Crestor

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Busan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Drug; DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)	Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin); DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period); Other Names: DWJ1351
Active Comparator: Reference Drug; Sevikar and Crestor	Drug: Sevikar and Crestor; Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period); Other Names: Amlodipine/Olmesartan and Rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	AUC	[ Time Frame: 0 - 72 hours ]
Cmax	Cmax	[ Time Frame: 0 - 72 hours ]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	AUCinf	[ Time Frame: 0 - 72 hours ]
Tmax	Tmax	[ Time Frame: 0 - 72 hours ]
t1/2β	t1/2β	[ Time Frame: 0 - 72 hours ]
CL/F	CL/F	[ Time Frame: 0 - 72 hours ]
Vdss/F	Vdss/F	[ Time Frame: 0 - 72 hours ]

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: JG Shin, Ph.D, Busan Paik Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): January 26, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Rosuvastatin Calcium; Olmesartan; Olmesartan Medoxomil; Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
• Other Study ID Numbers: DW_DWJ1351004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No