The Bioequivalence Study of Two Sunitinib Products in Capsules 50 mg in Healthy Volunteers Under Fasting Conditions

PHASE1UnknownINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 21, 2022

Primary Completion Date

March 3, 2022

Study Completion Date

May 3, 2022

Conditions
Bioequivalence
Interventions
DRUG

Aviga, capsules 50 mg / Sutent®, capsules 50 mg

Aviga is manufactured by JLLC NATIVITA, Republic of Belarus. Each capsule contains 50 mg of Sunitinib / Sutent® is manufactured by Pfizer Italia S.R.L., Italia. Each capsule contains 50 mg of Sunitinib.

DRUG

Sutent®, capsules 50 mg / Aviga, capsules 50 mg

Sutent® is manufactured by Pfizer Italia S.R.L., Italia. Each capsule contains 50 mg of Sunitinib / Aviga is manufactured by JLLC NATIVITA, Republic of Belarus. Each capsule contains 50 mg of Sunitinib

Trial Locations (1)

223040

National Anti-Doping Laboratory, Lyasny

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Anti Doping Laboratory, Belarus

UNKNOWN

lead

JLLC NatiVita

INDUSTRY