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Completed

NCT Number: NCT03753477

Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

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

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Busan Paik Hospital

Busan, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: DWJ1351

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)

Other names: Amlodipine/Olmesartan and Rosuvastatin

Primary outcomes

  1. AUC

    Time frame: [ Time Frame: 0 - 72 hours ]

    AUC

  2. Cmax

    Time frame: [ Time Frame: 0 - 72 hours ]

    Cmax

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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