Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802

LG Chem

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: Ezetimibe/Rosuvastatin; Drug: Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03532854

LG-EVCL001

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 6 patient groups

Sequence A

Experimental group

Description:

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

Treatment:

Drug: Valsartan

Drug: Ezetimibe/Rosuvastatin

Sequence B

Experimental group

Description:

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

Treatment:

Drug: Valsartan

Drug: Ezetimibe/Rosuvastatin

Sequence C

Experimental group

Description:

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

Treatment:

Drug: Valsartan

Drug: Ezetimibe/Rosuvastatin

Sequence D

Experimental group

Description:

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

Treatment:

Drug: Valsartan

Drug: Ezetimibe/Rosuvastatin

Sequence E

Experimental group

Description:

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

Treatment:

Drug: Valsartan

Drug: Ezetimibe/Rosuvastatin

Sequence F

Experimental group

Description:

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

Treatment:

Drug: Valsartan

Drug: Ezetimibe/Rosuvastatin