Pharmacokinetics
Conditions
Keywords
Everolimus, Healthy adults, Disperse formulation
Brief 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.
Interventions
DRUGSVG101 (T)
5mg of SVG101
DRUGAfinitor (R)
5mg of Afinitor
Sponsors
SoVarGen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults: 19y - 55y (Male or Female) 2. Male: more than 55kg, Female: more than 50kg body weight 3. Body mass index: more than 18.5kg/m\^2 and less than 27.0kg/m\^2 4. Menopause or surgical infertility female
Exclusion criteria
1. 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. 2. Participants with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 3. Any history of gastrointestinal disease or surgery 4. Participants have hypersensitive to the everolimus or other rapamycin derivatives or other components of the investigational product. 5. Taking any drugs that induce or inhibit metabolizing enzymes such as barbiturate drugs within 30 days prior to first administration 6. 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 7. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of Everolimus | up to 144 hours |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs) | up to approximately 45 days |
Countries
South Korea
Outcome results
None listed