NCT05490095

Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetic and Safety After Oral Administration of SVG101(Dispersible Tablet of Everolimus) 5mg and Afinitor 5mg in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sovargen · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the pharmacokinetics and safety of SVG101 (dispersible tab. of everolimus) in healthy volunteers compared to Afinitor tab. after oral administration.

Detailed description

This is a randomized, open-label, single-dose, two-way cross-over study to investigate the Pharmacokinetic characteristics and safety after oral administration of SVG101 (dispersible tablet of everolimus) 5mg and Afinitor 5mg in 26 healthy volunteers.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	SVG101 (T)	5mg of SVG101
DRUG	Afinitor (R)	5mg of Afinitor

Timeline

• Start date: 2021-07-23
• Primary completion: 2022-01-28
• Completion: 2022-02-07
• First posted: 2022-08-05
• Last updated: 2022-08-05

Locations

1 site across 1 country: South Korea