NCT03753477
Completed
Phase 1
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
Daewoong Pharmaceutical Co. LTD.1 site in 1 country64 target enrollmentDecember 22, 2017
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
- Conditions
- Healthy
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- AUC
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
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.
Investigators
Eligibility 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
Arms & Interventions
Test Drug
DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
Intervention: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
Reference Drug
Sevikar and Crestor
Intervention: Sevikar and Crestor
Outcomes
Primary Outcomes
AUC
Time Frame: [ Time Frame: 0 - 72 hours ]
AUC
Cmax
Time Frame: [ Time Frame: 0 - 72 hours ]
Cmax
Secondary Outcomes
- CL/F([ Time Frame: 0 - 72 hours ])
- AUCinf([ Time Frame: 0 - 72 hours ])
- Tmax([ Time Frame: 0 - 72 hours ])
- t1/2β([ Time Frame: 0 - 72 hours ])
- Vdss/F([ Time Frame: 0 - 72 hours ])
Study Sites (1)
Loading locations...
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