Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753477
• Other study ID #: DW_DWJ1351004
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: November 2018
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 1, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Busan Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC	AUC	[ Time Frame: 0 - 72 hours ]
Primary	Cmax	Cmax	[ Time Frame: 0 - 72 hours ]
Secondary	AUCinf	AUCinf	[ Time Frame: 0 - 72 hours ]
Secondary	Tmax	Tmax	[ Time Frame: 0 - 72 hours ]
Secondary	t1/2ß	t1/2ß	[ Time Frame: 0 - 72 hours ]
Secondary	CL/F	CL/F	[ Time Frame: 0 - 72 hours ]
Secondary	Vdss/F	Vdss/F	[ Time Frame: 0 - 72 hours ]