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

Phase 1

Completed

• Conditions: Rhinitis
• Interventions: Drug: HCP1102; Drug: Singulair and Xyzal

• Registration Number: NCT01651481
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TR	Singulair and Xyzal	HCP1102(Singulair and Xyzal combination tablet) -\> coadministration of Singulair and Xyzal
RT	Singulair and Xyzal	coadministration of Singulair and Xyzal -\> HCP1102(Singulair and Xyzal combination tablet)
RT	HCP1102	coadministration of Singulair and Xyzal -\> HCP1102(Singulair and Xyzal combination tablet)
TR	HCP1102	HCP1102(Singulair and Xyzal combination tablet) -\> coadministration of Singulair and Xyzal

Primary Outcome Measures

Name	Time	Method
AUClast	0-34hr
Cmax	0-34hr

Secondary Outcome Measures

Name	Time	Method
tmax	0-34hr
AUCinf	0-34hr
t1/2	0-34hr

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of