Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers
Not Applicable
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05531994
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TR Montelukast sodium chewable tablets with water (R) Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water. TR Montelukast sodium oral thin films with water (T) Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water. RT Montelukast sodium oral thin films with water (T) Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films with water. RT Montelukast sodium chewable tablets with water (R) Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films with water.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Haikou People's Hospital
🇨🇳Haikou, Hainan, China