Bioequivalence Study of Two Formulations of Febuxostat 120 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 3, 2019

Primary Completion Date

June 6, 2019

Study Completion Date

June 6, 2019

Conditions
Bioequivalence
Interventions
DRUG

Febuxostat

Febuxostat is manufactured by Pharmtechnology LLC, Republic of Belarus. Each film-coated tablet contains 120 mg of febuxostat.

DRUG

Adenuric

Adenuric is manufactured by Menarini - Von Heyden GmbH, Germany (MAH: Menarini International Operations Luxembourg S.A., Luxembourg). Each film-coated tablet contains 120 mg of febuxostat.

Trial Locations (1)

H3P 3P1

Altasciences Company Inc., Montreal

All Listed Sponsors
collaborator

Altasciences Company Inc.

INDUSTRY

lead

Pharmtechnology LLC

INDUSTRY

NCT03918551 - Bioequivalence Study of Two Formulations of Febuxostat 120 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions | Biotech Hunter | Biotech Hunter