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

NCT05528198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoai He · Haikou People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-28
Primary Completion
2019-05-14
Completion
2019-05-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05528198 on ClinicalTrials.gov