Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between LGEV1801 and LGEV1802 in Healthy Korean Male Volunteers
1 other identifier
interventional
42
1 country
1
Brief Summary
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 22, 2018
CompletedStudy Start
First participant enrolled
May 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedFebruary 15, 2019
February 1, 2019
3 months
May 8, 2018
February 13, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
AUCT,ss
Day 1~Day 8
Cmax,ss
Day 1~ Day 8
Study Arms (6)
Sequence A
EXPERIMENTALEzetimibe/Rosuvastatin -\> Valsartan -\> Valsartan and Ezetimibe/Rosuvastatin
Sequence B
EXPERIMENTALValsartan -\> Valsartan and Ezetimibe/Rosuvastatin-\> Ezetimibe/Rosuvastatin
Sequence C
EXPERIMENTALValsartan and Ezetimibe/Rosuvastatin -\> Ezetimibe/Rosuvastatin -\> Valsartan
Sequence D
EXPERIMENTALEzetimibe/Rosuvastatin -\> Valsartan and Ezetimibe/Rosuvastatin-\> Valsartan
Sequence E
EXPERIMENTALValsartan -\> Ezetimibe/Rosuvastatin -\> Valsartan and Ezetimibe/Rosuvastatin
Sequence F
EXPERIMENTALValsartan and Ezetimibe/Rosuvastatin -\> Valsartan -\> Ezetimibe/Rosuvastatin
Interventions
Valsartan P.O
Ezetimibe/Rosuvastatin P.O
Eligibility Criteria
You may qualify if:
- Healthy male
- Age between 19 and 50
- Subjects with BMI of 18\~27 kg/m2 with a weight of 55kg or more
- Subjects with SBP of 90\~150 mmHg and DBP of 60\~150 mmHg
- Signed informed consent
You may not qualify if:
- Presence of medical history or a concurrent disease
- Has a history of hypersensitivity to IP ingredients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Chemlead
Study Sites (1)
LG chem
Seoul, Gangseo-Gu, 07795, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2018
First Posted
May 22, 2018
Study Start
May 28, 2018
Primary Completion
August 25, 2018
Study Completion
January 30, 2019
Last Updated
February 15, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share