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
1 other identifier
interventional
28
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 25, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 13, 2013
August 1, 2013
2 months
July 25, 2012
August 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUClast
0-34hr
Cmax
0-34hr
Secondary Outcomes (3)
tmax
0-34hr
AUCinf
0-34hr
t1/2
0-34hr
Study Arms (2)
TR
EXPERIMENTALHCP1102(Singulair and Xyzal combination tablet) -\> coadministration of Singulair and Xyzal
RT
EXPERIMENTALcoadministration of Singulair and Xyzal -\> HCP1102(Singulair and Xyzal combination tablet)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male
- Age between 20 and 55
- Signed informed consent
You may not qualify if:
- Has a history of hypersensitivity to IP ingredients
- Hypotension or hypertension
- Has a history of acute infection within 14 days of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung medical center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2012
First Posted
July 27, 2012
Study Start
July 1, 2012
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
August 13, 2013
Record last verified: 2013-08