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
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 April 17, 2014