Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802

February 13, 2019 updated by: LG Chem

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
Ezetimibe/Rosuvastatin -> Valsartan -> Valsartan and Ezetimibe/Rosuvastatin
Drug: Valsartan
Valsartan P.O
Other Names:
  • Diovan
Drug: Ezetimibe/Rosuvastatin
Ezetimibe/Rosuvastatin P.O
Other Names:
  • Rosuzet
Experimental: Sequence B
Valsartan -> Valsartan and Ezetimibe/Rosuvastatin-> Ezetimibe/Rosuvastatin
Drug: Valsartan
Valsartan P.O
Other Names:
  • Diovan
Drug: Ezetimibe/Rosuvastatin
Ezetimibe/Rosuvastatin P.O
Other Names:
  • Rosuzet
Experimental: Sequence C
Valsartan and Ezetimibe/Rosuvastatin -> Ezetimibe/Rosuvastatin -> Valsartan
Drug: Valsartan
Valsartan P.O
Other Names:
  • Diovan
Drug: Ezetimibe/Rosuvastatin
Ezetimibe/Rosuvastatin P.O
Other Names:
  • Rosuzet
Experimental: Sequence D
Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin-> Valsartan
Drug: Valsartan
Valsartan P.O
Other Names:
  • Diovan
Drug: Ezetimibe/Rosuvastatin
Ezetimibe/Rosuvastatin P.O
Other Names:
  • Rosuzet
Experimental: Sequence E
Valsartan -> Ezetimibe/Rosuvastatin -> Valsartan and Ezetimibe/Rosuvastatin
Drug: Valsartan
Valsartan P.O
Other Names:
  • Diovan
Drug: Ezetimibe/Rosuvastatin
Ezetimibe/Rosuvastatin P.O
Other Names:
  • Rosuzet
Experimental: Sequence F
Valsartan and Ezetimibe/Rosuvastatin -> Valsartan -> Ezetimibe/Rosuvastatin
Drug: Valsartan
Valsartan P.O
Other Names:
  • Diovan
Drug: Ezetimibe/Rosuvastatin
Ezetimibe/Rosuvastatin P.O
Other Names:
  • Rosuzet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCT,ss
Time Frame: Day 1~Day 8
Day 1~Day 8
Cmax,ss
Time Frame: Day 1~ Day 8
Day 1~ Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2018

Primary Completion (Actual)

August 25, 2018

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-EVCL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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