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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01651481
First received: July 25, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Rhinitis
Drug: HCP1102
Drug: Singulair and Xyzal
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • AUClast [ Time Frame: 0-34hr ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 0-34hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tmax [ Time Frame: 0-34hr ] [ Designated as safety issue: No ]
  • AUCinf [ Time Frame: 0-34hr ] [ Designated as safety issue: No ]
  • t1/2 [ Time Frame: 0-34hr ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TR
HCP1102(Singulair and Xyzal combination tablet) -> coadministration of Singulair and Xyzal
Drug: HCP1102
Other Name: Singulair and Xyzal combination tablet
Drug: Singulair and Xyzal
Other Name: coadministration of Singulair and Xyzal
Experimental: RT
coadministration of Singulair and Xyzal -> HCP1102(Singulair and Xyzal combination tablet)
Drug: HCP1102
Other Name: Singulair and Xyzal combination tablet
Drug: Singulair and Xyzal
Other Name: coadministration of Singulair and Xyzal

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651481

Locations
Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01651481     History of Changes
Other Study ID Numbers: HM-MOLZ-102
Study First Received: July 25, 2012
Last Updated: August 12, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
Rhinitis

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Montelukast
Levocetirizine
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014