Study of DWJ1351 in Healthy Male Volunteers
A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers
1 other identifier
interventional
58
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jan 2016
Typical duration for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 20, 2016
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJanuary 28, 2016
January 1, 2016
5 months
January 20, 2016
January 25, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
AUC
0 - 144 hr
Cmax
0 - 144 hr
Study Arms (2)
AB
EXPERIMENTALSevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin) followed by DWJ1351
BA
EXPERIMENTALDWJ1351 followed by Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Subject who provided written informed consent to participate in this study
You may not qualify if:
- Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
- Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease
- 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 ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2016
First Posted
January 28, 2016
Study Start
January 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
January 28, 2016
Record last verified: 2016-01