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CompletedNCT01651481Updated Aug 13, 2013

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

A Phase 1 interventional study of HCP1102 and Singulair and Xyzal in Rhinitis, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-13.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Rhinitis

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Keywords

  • Rhinitis
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 28 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male
  • Age between 20 and 55
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Has a history of hypersensitivity to IP ingredients
  • Hypotension or hypertension
  • Has a history of acute infection within 14 days of screening
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    TR

    HCP1102(Singulair and Xyzal combination tablet) -\> coadministration of Singulair and Xyzal

    Drug: HCP1102 · Drug: Singulair and Xyzal

  • Experimental
    RT

    coadministration of Singulair and Xyzal -\> HCP1102(Singulair and Xyzal combination tablet)

    Drug: HCP1102 · Drug: Singulair and Xyzal

Interventions

  • DrugHCP1102

    Also known as: Singulair and Xyzal combination tablet

  • DrugSingulair and Xyzal

    Also known as: coadministration of Singulair and Xyzal

06

What researchers measure

Primary outcomes

  1. AUClast

    Time frame: 0-34hr

  2. Cmax

    Time frame: 0-34hr

Secondary outcomes

  1. tmax

    Time frame: 0-34hr

  2. AUCinf

    Time frame: 0-34hr

  3. t1/2

    Time frame: 0-34hr

07

Study locations

1 site
  • Samsung medical center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01651481
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Jul 27, 2012
Start date
Jul 2012
Primary completion
Sep 2012
Completion
Dec 2012
Last update
Aug 13, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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