Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

NCT03753477 | Completed Phase 1

• 1 other identifier: DW_DWJ1351004
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUC

  AUC

  [ Time Frame: 0 - 72 hours ]

• Cmax

  Cmax

  [ Time Frame: 0 - 72 hours ]

Secondary Outcomes (5)

• AUCinf

  [ Time Frame: 0 - 72 hours ]

• Tmax

  [ Time Frame: 0 - 72 hours ]

• t1/2β

  [ Time Frame: 0 - 72 hours ]

• CL/F

  [ Time Frame: 0 - 72 hours ]

• Vdss/F

  [ Time Frame: 0 - 72 hours ]

Study Arms (2)

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

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)

Also known as: DWJ1351

Test Drug

Sevikar and Crestor DRUG

Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)

Also known as: Amlodipine/Olmesartan and Rosuvastatin

Reference Drug

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; Amlodipine; olmesartan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines

Study Officials

• JG Shin, Ph.D

  Busan Paik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: November 27, 2018
• Study Start: December 22, 2017
• Primary Completion: January 26, 2018
• Study Completion: February 1, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

KR (1)