Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin

Hanmi Pharmaceutical Company Limited30 enrolled

Overview

The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

amosartanDRUG

rosuvastatinDRUG

amosartan and rosuvastatinDRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male * Age between 19 and 55 * Signed informed consent Exclusion Criteria: * Presence of medical history or a concurrent disease * Has a history of hypersensitivity to IP ingredients

Locations (1)

Samgsung Seoul Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Cmax

Time frame: 0-72h

AUClast

Time frame: 0-72h

Secondary Outcomes

tmax

Time frame: 0-72h

t1/2

Time frame: 0-72h

AUCinf

Time frame: 0-72h

Central Contacts

Jin-A Jung, Ph.D

CONTACT

jajung@hanmi.co.kr

Data from ClinicalTrials.gov

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