Clinical Trial to Investigate the Efficacy and Safety of DWJ1351
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)Drug: Sevikar and Crestor
- Registration Number
- NCT03753477
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Drug DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) Reference Drug Sevikar and Crestor Sevikar and Crestor
- Primary Outcome Measures
Name Time Method AUC [ Time Frame: 0 - 72 hours ] AUC
Cmax [ Time Frame: 0 - 72 hours ] Cmax
- Secondary Outcome Measures
Name Time Method CL/F [ Time Frame: 0 - 72 hours ] CL/F
AUCinf [ Time Frame: 0 - 72 hours ] AUCinf
Tmax [ Time Frame: 0 - 72 hours ] Tmax
t1/2β [ Time Frame: 0 - 72 hours ] t1/2β
Vdss/F [ Time Frame: 0 - 72 hours ] Vdss/F
Trial Locations
- Locations (1)
Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Busan Paik Hospital🇰🇷Busan, Korea, Republic of