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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05528198
• Other study ID #: QL-XZ1-013-01
• Status: Completed
• Phase: N/A
• Start date: December 28, 2018
• Est. completion date: May 14, 2019

Study information

• Verified date: May 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Montelukast sodium oral thin films without water (A)
Single-dose montelukast sodium oral thin film 5mg under fasted condition without water
• Montelukast sodium oral thin films with water (B)
Single-dose montelukast sodium oral thin film 5mg under fasted condition with water 240 mL
• Montelukast sodium chewable tablets with water (C)
Single-dose montelukast sodium chewable tablet 5mg under fasted condition with water 240 mL

Locations

Country	Name	City	State
China	Haikou People's Hospital	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	The maximum plasma drug concentration	0-24 hours
Primary	AUC0-t	The area under the concentration-time curve from dosing to time t	0-24 hours
Primary	AUC0-8	The area under the concentration-time curve extrapolated to infinity	0-24 hours