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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Montelukast sodium oral thin films without water (A); Drug: Montelukast sodium oral thin films with water (B); Drug: Montelukast sodium chewable tablets with water (C)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570100
      • Haikou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ABC; Administration order: montelukast sodium oral thin films without water, montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water.	Drug: Montelukast sodium oral thin films without water (A); Single-dose montelukast sodium oral thin film 5mg under fasted condition without water; Drug: Montelukast sodium oral thin films with water (B); Single-dose montelukast sodium oral thin film 5mg under fasted condition with water 240 mL; Drug: Montelukast sodium chewable tablets with water (C); Single-dose montelukast sodium chewable tablet 5mg under fasted condition with water 240 mL
Other: BCA; Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water.	Drug: Montelukast sodium oral thin films without water (A); Single-dose montelukast sodium oral thin film 5mg under fasted condition without water; Drug: Montelukast sodium oral thin films with water (B); Single-dose montelukast sodium oral thin film 5mg under fasted condition with water 240 mL; Drug: Montelukast sodium chewable tablets with water (C); Single-dose montelukast sodium chewable tablet 5mg under fasted condition with water 240 mL
Other: CAB; Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water, montelukast sodium oral thin films with water.	Drug: Montelukast sodium oral thin films without water (A); Single-dose montelukast sodium oral thin film 5mg under fasted condition without water; Drug: Montelukast sodium oral thin films with water (B); Single-dose montelukast sodium oral thin film 5mg under fasted condition with water 240 mL; Drug: Montelukast sodium chewable tablets with water (C); Single-dose montelukast sodium chewable tablet 5mg under fasted condition with water 240 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: XiaoAi He, Haikou People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2018
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): May 14, 2019

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: QL-XZ1-013-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No