To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.
This study evaluates the pharmacokinetic characteristics and safety of pranlukast in healthy adults. It is a randomized, open-label, single-dose, two-period crossover trial conducted under fasting conditions. Pharmacokinetic samples are collected up to 24 hours after dosing, and standard safety assessments are performed throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
H Plus Yangji Hospital
Seoul, South Korea
Cmax of Pranlukast
To assess the maximum observed plasma concentration (Cmax) of Pranlukast
Time frame: 0 hour ~ 24 hour after drug administration
AUCt of Pranlukast
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Pranlukast
Time frame: 0 hour ~ 24 hour after drug administration
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