Study to evaluate the drug-drug interaction between montelukast and levocetirizine in health male volunteers.

Open-label, randomized, 6-sequence crossover study to evaluate the drug-drug interaction between montelukast sodium and levocetirizine dihydrochloride in healthy male volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000303

Enrollment

Registered

2011-12-27

Start date

2011-11-18

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : montelukast 10mg or levocetirizine 5mg or montelukast 10mg+levocetirizine 5mg Single dose, Cross-over Oral medication

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy male volunteer Age between 20 and 55

Exclusion criteria

Exclusion criteria: Has a history of hypersensitivity to IP ingredients Hypotension or hypertension Has a history of acute infection within 14days of screening

Design outcomes

Primary

Measure	Time frame
AUClast;Cmax	—

Secondary

Measure	Time frame
AUCinf	—

Countries

Korea, Republic of

Contacts

Public Contactsukran kim

Samsung Medical Center

Outcome results