NCT03898193View on ClinicalTrials.gov

Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

March 23, 2019

Primary Completion Date

April 8, 2019

Study Completion Date

April 8, 2019

Conditions
Healthy Adults
Interventions
DRUG

Montelukast

Montelukast, 5 mg Chewable Tablets, manufactured by Pharmtechnology LLC, Republic of Belarus

DRUG

Singulair

Singulair, 5 mg Chewable Tablets, marketed by Merck Sharp \& Dohme B.V., the Netherlands

Trial Locations (1)

150010

"State Autonomous Healthcare Facility of the Yaroslavl Region Clinical Hospital No. 2", Yaroslavl

All Listed Sponsors
collaborator

ClinPharmInvest, LLC

OTHER

lead

Pharmtechnology LLC

INDUSTRY

NCT03898193 - Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions | Biotech Hunter | Biotech Hunter