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OpenTrials
Completed

NCT Number: NCT05490095

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

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.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei University Healthcare System, Severance Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SVG101 (T)

Drug

5mg of SVG101

Afinitor (R)

Drug

5mg of Afinitor

Primary outcomes

  1. AUCinf of everolimus

    Time frame: up to 144 hours

  2. Cmax of Everolimus

    Time frame: up to 144 hours

  3. Cmin,ss,pred of Everolimus

    Time frame: up to 144 hours

  4. AUClast of Everolimus

    Time frame: up to 144 hours

  5. Tmax of Everolimus

    Time frame: up to 144 hours

  6. t1/2 of Everolimus

    Time frame: up to 144 hours

  7. Vd/F of Everolimus

    Time frame: up to 144 hours

  8. Clearance of Everolimus

    Time frame: up to 144 hours

Secondary outcomes

  1. Adverse Events (AEs)

    Time frame: up to approximately 45 days

Sponsors and collaborators

Lead sponsor

Sovargen

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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