Healthy Male Volunteers Clinical Trial
Official title:
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
| Verified date | February 2019 |
| Source | LG Chem |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | January 30, 2019 |
| Est. primary completion date | August 25, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 19 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | LG chem | Seoul | Gangseo-Gu |
| Lead Sponsor | Collaborator |
|---|---|
| LG Chem |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AUCT,ss | Day 1~Day 8 | ||
| Primary | Cmax,ss | Day 1~ Day 8 |
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