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OpenTrials
Completed

NCT Number: NCT03532854

Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802

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

Completed

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Key information

Conditions

Healthy Male Volunteers

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

LG chem

Seoul, Gangseo-Gu, 07795, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

Valsartan P.O

Other names: Diovan

Ezetimibe/Rosuvastatin

Drug

Ezetimibe/Rosuvastatin P.O

Other names: Rosuzet

Primary outcomes

  1. AUCT,ss

    Time frame: Day 1~Day 8

  2. Cmax,ss

    Time frame: Day 1~ Day 8

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 22, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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