Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

NCT03753477 — Phase 1, Completed, 64 participants, Daewoong Pharmaceutical Co. LTD.

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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

Registry	NCT03753477
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	64 (Actual)
Sponsor	Daewoong Pharmaceutical Co. LTD. (Industry)
Conditions	Healthy
Interventions	DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin), Sevikar and Crestor (Drug)
Dates	start 2017-12-22, primary completion 2018-01-26, completion 2018-02-01, first posted 2018-11-27, last updated 2018-11-28
Locations	1 site in South Korea

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Test Drug	Experimental	Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)	DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
Reference Drug	Active comparator	Drug: Sevikar and Crestor	Sevikar and Crestor

DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) (Drug), also known as DWJ1351: 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)
Sevikar and Crestor (Drug), also known as Amlodipine/Olmesartan and Rosuvastatin: Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)

+Outcome measures

Primary outcomes

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

Secondary outcomes

AUCinf [[ Time Frame: 0 - 72 hours ]]: AUCinf
Tmax [[ Time Frame: 0 - 72 hours ]]: Tmax
t1/2β [[ Time Frame: 0 - 72 hours ]]: t1/2β
CL/F [[ Time Frame: 0 - 72 hours ]]: CL/F
Vdss/F [[ Time Frame: 0 - 72 hours ]]: Vdss/F

+Eligibility

Sex: Male, ages: 19 Years to 50 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Busan Paik Hospital	Busan	South Korea

+Investigators

JG Shin, Ph.D, Principal investigator, Busan Paik Hospital

My Notes

Public

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