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

NCT ID: NCT05531994

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2019-05-14

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TR

Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water.

Group Type: OTHER

Montelukast sodium oral thin films with water (T)

Intervention Type: DRUG

Single-dose montelukast sodium oral thin film 5mg under fed condition with water 240 mL

Montelukast sodium chewable tablets with water (R)

Intervention Type: DRUG

Single-dose montelukast sodium chewable tablet 5mg under fed condition with water 240 mL

RT

Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films with water.

Group Type: OTHER

Montelukast sodium oral thin films with water (T)

Intervention Type: DRUG

Single-dose montelukast sodium oral thin film 5mg under fed condition with water 240 mL

Montelukast sodium chewable tablets with water (R)

Intervention Type: DRUG

Single-dose montelukast sodium chewable tablet 5mg under fed condition with water 240 mL

Interventions

Montelukast sodium oral thin films with water (T)

Single-dose montelukast sodium oral thin film 5mg under fed condition with water 240 mL

Intervention Type: DRUG

Montelukast sodium chewable tablets with water (R)

Single-dose montelukast sodium chewable tablet 5mg under fed condition with water 240 mL

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoai He

Role: PRINCIPAL_INVESTIGATOR

Haikou People's Hospital

Locations

Haikou People's Hospital

Haikou, Hainan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36819512 (View on PubMed)

Other Identifiers

QL-XZ1-013-02

Identifier Type: -

Identifier Source: org_study_id