NCT05528198View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 28, 2018

Primary Completion Date

May 14, 2019

Study Completion Date

May 14, 2019

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

Trial Locations (1)

570100

Haikou People's Hospital, Haikou

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

NCT05528198 - Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fasted Healthy Volunteers | Biotech Hunter | Biotech Hunter