Bioequivalence Study of Montelukast Sodium Oral Thin Film... | NCT05531994

NCT05531994

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TR	Other	Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water.	Drug: Montelukast sodium oral thin films with water (T) Drug: Montelukast sodium chewable tablets with water (R)
RT	Other	Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films with water.	Drug: Montelukast sodium oral thin films with water (T) Drug: Montelukast sodium chewable tablets with water (R)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montelukast sodium oral thin films with water (T)	Drug	Single-dose montelukast sodium oral thin film 5mg under fed condition with water 240 mL	RT TR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax	The maximum plasma drug concentration	0-24 hours
AUC0-t	The area under the concentration-time curve from dosing to time t	0-24 hours
AUC0-∞	The area under the concentration-time curve extrapolated to infinity	0-24 hours

Eligibility Module

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

Name	Affiliation	Role
Xiaoai He	Haikou People's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Haikou People's Hospital		Haikou	Hainan	570100	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36819512	Derived	Zhu G, Wang L, Han S, Peng H, Tong M, Gu X, Hu H, Wang Y, Lv Z, He X. Pharmacokinetics and bioequivalence study of montelukast sodium oral soluble film and chewable tablet in healthy Chinese volunteers: randomized trials under fasting and fed conditions. Ann Transl Med. 2023 Jan 31;11(2):93. doi: 10.21037/atm-22-6485.

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477