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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Rhinitis

Treatments: Drug: HCP1102; Drug: Singulair and Xyzal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651481

HM-MOLZ-102

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

TR

Experimental group

Description:

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

Treatment:

Drug: Singulair and Xyzal

Drug: HCP1102

RT

Experimental group

Description:

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

Treatment:

Drug: Singulair and Xyzal

Drug: HCP1102