Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination

Hanmi Pharmaceutical Company Limited28 enrolled

Overview

The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg) and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rhinitis

Interventions

HCP1102DRUG

Singulair and XyzalDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male * Age between 20 and 55 * Signed informed consent Exclusion Criteria: * Has a history of hypersensitivity to IP ingredients * Hypotension or hypertension * Has a history of acute infection within 14 days of screening

Locations (1)

Samsung medical center

Seoul, South Korea

Outcomes

Primary Outcomes

AUClast

Time frame: 0-34hr

Cmax

Time frame: 0-34hr

Secondary Outcomes

tmax

Time frame: 0-34hr

AUCinf

Time frame: 0-34hr

t1/2

Time frame: 0-34hr

Data from ClinicalTrials.gov

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