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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 28, 2022

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

  • Drug: SVG101 (T)
    • 5mg of SVG101
  • Drug: Afinitor (R)
    • 5mg of Afinitor

Arms, Groups and Cohorts

  • Experimental: Group I
    • 13 subjects will receive First Dose: Afinitor 5mg, single dose Wash out period : more than 10 days Second Dose: SVG101 5mg, single dose
  • Experimental: Group II
    • 13 subjects will receive First Dose: SVG101 5mg, single dose Wash out period : more than 10 days Second Dose: Afinitor 5mg, single dose

Clinical Trial Outcome Measures

Primary Measures

  • AUCinf of everolimus
    • Time Frame: up to 144 hours
  • Cmax of Everolimus
    • Time Frame: up to 144 hours
  • Cmin,ss,pred of Everolimus
    • Time Frame: up to 144 hours
  • AUClast of Everolimus
    • Time Frame: up to 144 hours
  • Tmax of Everolimus
    • Time Frame: up to 144 hours
  • t1/2 of Everolimus
    • Time Frame: up to 144 hours
  • Vd/F of Everolimus
    • Time Frame: up to 144 hours
  • Clearance of Everolimus
    • Time Frame: up to 144 hours

Secondary Measures

  • Adverse Events (AEs)
    • Time Frame: up to approximately 45 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • SoVarGen Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eric J Maeng, Study Director, SoVarGen Co., Ltd.

References

Lim JS, Kim WI, Kang HC, Kim SH, Park AH, Park EK, Cho YW, Kim S, Kim HM, Kim JA, Kim J, Rhee H, Kang SG, Kim HD, Kim D, Kim DS, Lee JH. Brain somatic mutations in MTOR cause focal cortical dysplasia type II leading to intractable epilepsy. Nat Med. 2015 Apr;21(4):395-400. doi: 10.1038/nm.3824. Epub 2015 Mar 23.

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