A Drug Interaction Study of Montelukast and Levocetirizine (MOLZ)

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Montelukast & levocetirizine; Drug: Levocetirizine; Drug: montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01491503

HM-MOLZ-101

Details and patient eligibility

About

The purpose of this study is to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers.

Enrollment: 30 estimated patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: No 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 14days of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Montelukast and levocetirizine

Experimental group

Treatment:

Drug: Montelukast & levocetirizine

Montelukast

Active Comparator group

Treatment:

Drug: montelukast sodium

Levocetirizine

Active Comparator group

Treatment:

Drug: Levocetirizine