Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 134 for:    OLMESARTAN

Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

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.
 
ClinicalTrials.gov Identifier: NCT03753477
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : November 28, 2018
Sponsor:
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(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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : December 22, 2017
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : February 1, 2018


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 Name: 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 Name: Amlodipine/Olmesartan and Rosuvastatin




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

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


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

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

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

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

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



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.


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

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 ClinicalTrials.gov identifier (NCT number): NCT03753477


Locations
Layout table for location information
Korea, Republic of
Busan Paik Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
Layout table for investigator information
Principal Investigator: JG Shin, Ph.D Busan Paik Hospital

Layout table for additonal information
Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT03753477     History of Changes
Other Study ID Numbers: DW_DWJ1351004
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Olmesartan
Olmesartan Medoxomil
Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
Amlodipine
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
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists