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

Qilu Pharmaceutical

Status

Completed

Conditions

Healthy Volunteers

Treatments

Drug: Montelukast sodium chewable tablets with water (R)

Drug: Montelukast sodium oral thin films with water (T)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05531994

QL-XZ1-013-02

Details and patient eligibility

About

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 fed condition.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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