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PO1-11-31

Pharmacokinetic comparison of HCP1102 and co-administration of montelukast and levocetirizine in healthy male volunteers

[Speaker] So Jin Lee:1
[Co-author] Ji-Young Jeon:1, Seol Ju Moon:1, Min-Gul Kim:1,2, Kyungho Jang:1
1:Biomedical Research Institute, Chonbuk National University Hospital, Center for Clinical Pharmacology, Korea, 2:Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, Korea

BACKGROUND: A fixed-dose combination (FDC) of levocetirizine and montelukast is expected to provide complementary effects, which improve the rhinitis symptoms and allergic rhinitis. The objective of the study was to compare the pharmacokinetics and safety of HCP1102(montelukast 5 mg and levocetirizine 5 mg FDC) to co-administration of individual tablets in healthy male volunteers.
METHODS: This study was designed as a randomized, open-label, single dose, crossover study in healthy male subjects. A total of 24 subjects were randomly assigned to 1 of 2 sequences and received either the test drug HCP1102 (montelukast 5 mg/levocetirizine 5 mg FDC) or reference drug (montelukast 5 mg and levocetirizine 5 mg) in each period. Serial blood samples were collected pre-dose and up to 48 hours post-dose. Safety assessments were performed.
RESULTS: Twenty-two subjects were included in the pharmacokinetic analysis. The 90% confidence intervals for geometric mean ratios (test/reference) of AUClast and Cmax of montelukast and levocetirizine were all between 0.80 and 1.25. There was no serious adverse event and all reported adverse events were mild.
CONCLUSIONS: HCP1102 (montelukast 5 mg/levocetirizine 5 mg FDC) was bioequivalent to co-administration of individual tablets. Both formulations were safe and no significant difference was observed in the safety assessments of the treatments.
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