Clinical Trial to Investigate the Efficacy and Safety of... | NCT03753477

Studies
Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

NCT03753477

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Nov 28, 2018Actual

Enrollment

64Actual

Phase

Phase 1

Conditions

Healthy

Interventions

DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
Sevikar and Crestor

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2017Actual

Primary Completion Date

Jan 26, 2018Actual

Completion Date

Feb 1, 2018Actual

First Submitted Date

Feb 14, 2018

First Submission Date that Met QC Criteria

Nov 22, 2018

First Posted Date

Nov 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2018

Last Update Posted Date

Nov 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Drug	Experimental	DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)	Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
Reference Drug	Active Comparator	Sevikar and Crestor	Drug: Sevikar and Crestor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)	Drug	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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
AUCinf	AUCinf	[ Time Frame: 0 - 72 hours ]
Tmax	Tmax	[ Time Frame: 0 - 72 hours ]

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
JG Shin, Ph.D	Busan Paik Hospital	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium
D017311	Amlodipine
C437965	olmesartan

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

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Browse Branches

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