Clinical trial NCT05528198: Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fasted Healthy Volunteers
Official title: A Randomized, Open-label, Three-period, Three-sequence, Crossover, Single-dose Bioequivalence Study of Montelukast Sodium Oral Thin Films in Healthy Chinese Volunteers Under Fasted Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 fasted condition.


Eligibility criteria: 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

Primary outcomes:
measure: Cmax
timeFrame: 0-24 hours
measure: AUC0-t
timeFrame: 0-24 hours
measure: AUC0-∞
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haikou
country: China
facility: Haikou People's Hospital
state: Hainan
Study officials:
affiliation: Haikou People's Hospital
name: Xiaoai He
role: PRINCIPAL_INVESTIGATOR
References: