NCT05528198

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-28
• Primary completion: 2019-05-14
• Completion: 2019-05-14
• First posted: 2022-09-06
• Last updated: 2023-05-11

Locations

1 site across 1 country: China