Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fasted Healthy Volunteers

Inclusion criteria

• Fully understood and voluntarily signed the informed consent form
• With high compliance
• BMI 18.6-28.5 kg/m^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female

Exclusion criteria

• Allergic to any component of study drugs, other leukotriene receptor antagonists, sulfonamides, or non-steroidal anti-inflammatory drugs
• With clinically relevantly abnormal vital sign, examination, or clinically relevant disease
• Had drug abuse within 3 months before screening or positive in drug of abuse test
• With any routine use of drugs
• Received major surgery within 6 months before study drug administration or planned to receive major surgery during study period
• With average number of cigarettes smoked > 5/day within 3 months before screening or refused to suspend smoking from 24 hours before study drug administration throughout study period
• With average alcohol consumption > 14 units/week within 6 months before screening or refused to suspend alcohol consumption from 24 hours before study drug administration throughout study period
• With average tea, coffee, or other drink with caffeine consumption > 8*250 mL/day, or refused to suspend tea, coffee, other drink with caffeine, or grape fruit juice consumption from 24 hours before study drug administration throughout study period
• Lost or donated blood > 200 mL within 3 months, or donated platelet > 24 U within 1 months before study drug administration
• Received any drug within 14 days before study drug administration
• Received any drug of other clinical trial within 3 months before study drug administration
• Received any vaccine within 4 weeks before study drug administration
• Planned for pregnancy within 3 months after informed consent form signed or refused to use adequate contraception (excluding contraceptive drug)
• For female, pregnant, breastfeeding, received oral contraceptives within 30 days, or contraceptive injection or implant within 6 months before study drug administration
• For pregnancy-capable female, had unprotected sexual contact within 14 days before study drug administration