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

NCT05528198 | Completed

• 1 other identifier: QL-XZ1-013-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

ABC

OTHER

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); Drug: Montelukast sodium oral thin films with water (B); Drug: Montelukast sodium chewable tablets with water (C)

BCA

OTHER

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); Drug: Montelukast sodium oral thin films with water (B); Drug: Montelukast sodium chewable tablets with water (C)

CAB

OTHER

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); Drug: Montelukast sodium oral thin films with water (B); Drug: Montelukast sodium chewable tablets with water (C)

Interventions

Montelukast sodium oral thin films without water (A) DRUG

Single-dose montelukast sodium oral thin film 5mg under fasted condition without water

ABC; BCA; CAB

Montelukast sodium oral thin films with water (B) DRUG

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

ABC; BCA; CAB

Montelukast sodium chewable tablets with water (C) DRUG

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

ABC; BCA; CAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Haikou People's Hospital

Haikou, Hainan, 570100, China

Location

Related Publications (1)

• 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.

  PMID: 36819512 DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Xiaoai He

  Haikou People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: December 28, 2018
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

CN (1)