Clincosm LogoSign in Get a demo

Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT03753477
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
1.3
Actual Duration (Months)
47.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
  • Drug: Sevikar and Crestor
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 22, 2017
Actual Primary Completion Date :
Jan 26, 2018
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC [[ Time Frame: 0 - 72 hours ]]

      AUC

    2. Cmax [[ Time Frame: 0 - 72 hours ]]

      Cmax

    Secondary Outcome Measures

    1. AUCinf [[ Time Frame: 0 - 72 hours ]]

      AUCinf

    2. Tmax [[ Time Frame: 0 - 72 hours ]]

      Tmax

    3. t1/2β [[ Time Frame: 0 - 72 hours ]]

      t1/2β

    4. CL/F [[ Time Frame: 0 - 72 hours ]]

      CL/F

    5. Vdss/F [[ Time Frame: 0 - 72 hours ]]

      Vdss/F

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Busan Paik Hospital Busan Korea, Republic of

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    • Principal Investigator: JG Shin, Ph.D, Busan Paik Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT03753477
    Other Study ID Numbers:
    • DW_DWJ1351004
    First Posted:
    Nov 27, 2018
    Last Update Posted:
    Nov 28, 2018
    Last Verified:
    Nov 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Amlodipine
    Olmesartan
    Olmesartan Medoxomil
    Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Nov 28, 2018