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NCT01651481 Clinical Trial

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

Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01651481
Other study ID # HM-MOLZ-102
Secondary ID
Status Completed
Phase Phase 1
First received July 25, 2012
Last updated August 12, 2013
Start date July 2012
Est. completion date December 2012

Study information
Verified date August 2013
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• HCP1102

• Singulair and Xyzal

Locations
Country Name City State
Korea, Republic of Samsung medical center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUClast 0-34hr No
Primary Cmax 0-34hr No
Secondary tmax 0-34hr No
Secondary AUCinf 0-34hr No
Secondary t1/2 0-34hr No
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