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Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802

NCT ID: NCT03532854

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2019-01-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

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

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan P.O

Ezetimibe/Rosuvastatin

Intervention Type DRUG

Ezetimibe/Rosuvastatin P.O

Sequence B

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

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan P.O

Ezetimibe/Rosuvastatin

Intervention Type DRUG

Ezetimibe/Rosuvastatin P.O

Sequence C

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

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan P.O

Ezetimibe/Rosuvastatin

Intervention Type DRUG

Ezetimibe/Rosuvastatin P.O

Sequence D

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

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan P.O

Ezetimibe/Rosuvastatin

Intervention Type DRUG

Ezetimibe/Rosuvastatin P.O

Sequence E

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

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan P.O

Ezetimibe/Rosuvastatin

Intervention Type DRUG

Ezetimibe/Rosuvastatin P.O

Sequence F

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

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan P.O

Ezetimibe/Rosuvastatin

Intervention Type DRUG

Ezetimibe/Rosuvastatin P.O

Interventions

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Valsartan

Valsartan P.O

Intervention Type DRUG

Ezetimibe/Rosuvastatin

Ezetimibe/Rosuvastatin P.O

Intervention Type DRUG

Other Intervention Names

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Diovan Rosuzet

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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LG chem

Seoul, Gangseo-Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LG-EVCL001

Identifier Type: -

Identifier Source: org_study_id

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