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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: SVG101 (T)
* Drug: Afinitor (R)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults: 19y - 55y (Male or Female) Male: more than 55kg, Female: more than 50kg body weight Body mass index: more than 18.5kg/m^2 and less than 27.0kg/m^2 Menopause or surgical infertility female Exclusion Criteria: Participants have or had a history of the clinically relevant disease or abnormalities in the hepatobiliary system, kidney, nervous system, immune system, respiratory system, urinary system, digestive system, endocrine system, blood/tumor, cardiovascular system, and mental illness. Participants with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Any history of gastrointestinal disease or surgery Participants have hypersensitive to the everolimus or other rapamycin derivatives or other components of the investigational product. Taking any drugs that induce or inhibit metabolizing enzymes such as barbiturate drugs within 30 days prior to first administration Receiving any investigational therapy of others within 180 days prior to first administration. In case of biological products, the restricted period can be extended depend on the half-life receipt product Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>13 subjects will receive First Dose: Afinitor 5mg, single dose Wash out period : more than 10 days Second Dose: SVG101 5mg, single dose | Drug: SVG101 (T)<br>* 5mg of SVG101<br>Drug: Afinitor (R)<br>* 5mg of Afinitor<br>|
| Experimental: Group II<br>13 subjects will receive First Dose: SVG101 5mg, single dose Wash out period : more than 10 days Second Dose: Afinitor 5mg, single dose | Drug: SVG101 (T)<br>* 5mg of SVG101<br>Drug: Afinitor (R)<br>* 5mg of Afinitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of everolimus |  | up to 144 hours | 
| Cmax of Everolimus |  | up to 144 hours | 
| Cmin,ss,pred of Everolimus |  | up to 144 hours | 
| AUClast of Everolimus |  | up to 144 hours | 
| Tmax of Everolimus |  | up to 144 hours | 
| t1/2 of Everolimus |  | up to 144 hours | 
| Vd/F of Everolimus |  | up to 144 hours | 
| Clearance of Everolimus |  | up to 144 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) |  | up to approximately 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Everolimus, Healthy adults, Disperse formulation