NCT05218616

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

Single-dose, Open-label, 2 Periods, 2 Sequences, Randomized Crossover Bioequivalence Study of Aviga 50 mg Capsules (JLLC NATIVITA, Belarus) and Sutent 50 mg Capsules (Pfizer Italia S.R.L.) in Healthy Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: JLLC NatiVita · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study is designed in accordance with the Eurasian Economic Union (EAEU) regulatory guidelines, with the aim of characterizing the bioavailability of two pharmaceutical products of sunitinib in healthy adult volunteers. Within the clinical portion of the study, each volunteer will receive a single oral dose of the test and the reference product in compliance with the generated randomization code.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-21
• Primary completion: 2022-03-03
• Completion: 2022-05-03
• First posted: 2022-02-01
• Last updated: 2022-02-01

Locations

1 site across 1 country: Belarus