Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802
Phase 1
Completed
- Conditions
- Healthy Male Volunteers
- Interventions
- Drug: Ezetimibe/Rosuvastatin
- Registration Number
- NCT03532854
- Lead Sponsor
- LG Chem
- Brief Summary
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
Inclusion Criteria
- 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
Exclusion Criteria
- Presence of medical history or a concurrent disease
- Has a history of hypersensitivity to IP ingredients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A Ezetimibe/Rosuvastatin Ezetimibe/Rosuvastatin -\> Valsartan -\> Valsartan and Ezetimibe/Rosuvastatin Sequence B Ezetimibe/Rosuvastatin Valsartan -\> Valsartan and Ezetimibe/Rosuvastatin-\> Ezetimibe/Rosuvastatin Sequence C Ezetimibe/Rosuvastatin Valsartan and Ezetimibe/Rosuvastatin -\> Ezetimibe/Rosuvastatin -\> Valsartan Sequence D Ezetimibe/Rosuvastatin Ezetimibe/Rosuvastatin -\> Valsartan and Ezetimibe/Rosuvastatin-\> Valsartan Sequence E Ezetimibe/Rosuvastatin Valsartan -\> Ezetimibe/Rosuvastatin -\> Valsartan and Ezetimibe/Rosuvastatin Sequence F Ezetimibe/Rosuvastatin Valsartan and Ezetimibe/Rosuvastatin -\> Valsartan -\> Ezetimibe/Rosuvastatin Sequence B Valsartan Valsartan -\> Valsartan and Ezetimibe/Rosuvastatin-\> Ezetimibe/Rosuvastatin Sequence A Valsartan Ezetimibe/Rosuvastatin -\> Valsartan -\> Valsartan and Ezetimibe/Rosuvastatin Sequence C Valsartan Valsartan and Ezetimibe/Rosuvastatin -\> Ezetimibe/Rosuvastatin -\> Valsartan Sequence D Valsartan Ezetimibe/Rosuvastatin -\> Valsartan and Ezetimibe/Rosuvastatin-\> Valsartan Sequence E Valsartan Valsartan -\> Ezetimibe/Rosuvastatin -\> Valsartan and Ezetimibe/Rosuvastatin Sequence F Valsartan Valsartan and Ezetimibe/Rosuvastatin -\> Valsartan -\> Ezetimibe/Rosuvastatin
- Primary Outcome Measures
Name Time Method AUCT,ss Day 1~Day 8 Cmax,ss Day 1~ Day 8
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
LG chem
🇰🇷Seoul, Gangseo-Gu, Korea, Republic of