CClinicalTrials.gg
Sign In
CompletedNCT03532854Updated Feb 15, 2019

Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802

A Phase 1 interventional study of Valsartan and Ezetimibe/Rosuvastatin in Healthy Male Volunteers, sponsored by LG Chem. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by LG Chem · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy Male Volunteers
03

In context

Lead sponsor

LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Male
Accepts 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

Exclusion Criteria:

  • Presence of medical history or a concurrent disease
  • Has a history of hypersensitivity to IP ingredients
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Sequence A

    Ezetimibe/Rosuvastatin -\> Valsartan -\> Valsartan and Ezetimibe/Rosuvastatin

    Drug: Valsartan · Drug: Ezetimibe/Rosuvastatin

  • Experimental
    Sequence B

    Valsartan -\> Valsartan and Ezetimibe/Rosuvastatin-\> Ezetimibe/Rosuvastatin

    Drug: Valsartan · Drug: Ezetimibe/Rosuvastatin

  • Experimental
    Sequence C

    Valsartan and Ezetimibe/Rosuvastatin -\> Ezetimibe/Rosuvastatin -\> Valsartan

    Drug: Valsartan · Drug: Ezetimibe/Rosuvastatin

  • Experimental
    Sequence D

    Ezetimibe/Rosuvastatin -\> Valsartan and Ezetimibe/Rosuvastatin-\> Valsartan

    Drug: Valsartan · Drug: Ezetimibe/Rosuvastatin

  • Experimental
    Sequence E

    Valsartan -\> Ezetimibe/Rosuvastatin -\> Valsartan and Ezetimibe/Rosuvastatin

    Drug: Valsartan · Drug: Ezetimibe/Rosuvastatin

  • Experimental
    Sequence F

    Valsartan and Ezetimibe/Rosuvastatin -\> Valsartan -\> Ezetimibe/Rosuvastatin

    Drug: Valsartan · Drug: Ezetimibe/Rosuvastatin

Interventions

  • DrugValsartan

    Valsartan P.O

    Also known as: Diovan

  • DrugEzetimibe/Rosuvastatin

    Ezetimibe/Rosuvastatin P.O

    Also known as: Rosuzet

06

What researchers measure

Primary outcomes

  1. AUCT,ss

    Time frame: Day 1~Day 8

  2. Cmax,ss

    Time frame: Day 1~ Day 8

07

Study locations

1 site
  • LG chem
    Seoul, Gangseo-Gu 07795, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03532854
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
May 22, 2018
Start date
May 28, 2018
Primary completion
Aug 25, 2018
Completion
Jan 30, 2019
Last update
Feb 15, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

LG Chem

Start the discussion