This study aimed to evaluate the pharmacokinetic characteristics of montelukast sodium oral thin films and the bioequivalence between oral thin films and chewable tablets in healthy chinese volunteers under fasted condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Single-dose montelukast sodium oral thin film 5mg under fasted condition without water
Single-dose montelukast sodium oral thin film 5mg under fasted condition with water 240 mL
Single-dose montelukast sodium chewable tablet 5mg under fasted condition with water 240 mL
Haikou People's Hospital
Haikou, Hainan, China
Cmax
The maximum plasma drug concentration
Time frame: 0-24 hours
AUC0-t
The area under the concentration-time curve from dosing to time t
Time frame: 0-24 hours
AUC0-∞
The area under the concentration-time curve extrapolated to infinity
Time frame: 0-24 hours
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