Randomized Crossover of SVG101(Dispersible Tab. of Everolimus) and Afinitor 5mg in Healthy Adults
NCT05490095 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2022-08-05
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.
Conditions
- Pharmacokinetics
Interventions
- DRUG
-
SVG101 (T)
5mg of SVG101
- DRUG
-
Afinitor (R)
5mg of Afinitor
Sponsors & Collaborators
-
SoVarGen Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Eric J Maeng · SoVarGen Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-23
- Primary Completion
- 2022-01-28
- Completion
- 2022-02-07
Countries
- South Korea
Study Locations
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