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

Open-label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics and Safety of Singulair (10 mg) and Xyzal (5 mg) in Free Combination and Fixed-dose Combination as HCP1102 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01651481

Enrollment

Registered

2012-07-27

Start date

2012-07-31

Completion date

2012-12-31

Last updated

2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis

Keywords

Rhinitis

Brief summary

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

Interventions

DRUGHCP1102

DRUGSingulair and Xyzal

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUClast	0-34hr
Cmax	0-34hr

Secondary

Measure	Time frame
tmax	0-34hr
AUCinf	0-34hr
t1/2	0-34hr

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026