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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03532854
Enrollment
42
Registered
2018-05-22
Start date
2018-05-28
Completion date
2019-01-30
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Volunteers

Brief summary

The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.

Interventions

DRUGValsartan

Valsartan P.O

DRUGEzetimibe/Rosuvastatin

Ezetimibe/Rosuvastatin P.O

Sponsors

LG Chem
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
AUCT,ssDay 1~Day 8
Cmax,ssDay 1~ Day 8

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026