Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGMontelukast sodium oral thin films with water (T)
Single-dose montelukast sodium oral thin film 5mg under fed condition with water 240 mL
DRUGMontelukast sodium chewable tablets with water (R)
Single-dose montelukast sodium chewable tablet 5mg under fed condition with water 240 mL
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0-24 hours | The maximum plasma drug concentration |
| AUC0-t | 0-24 hours | The area under the concentration-time curve from dosing to time t |
| AUC0-∞ | 0-24 hours | The area under the concentration-time curve extrapolated to infinity |
Countries
China
Outcome results
None listed