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

• Status: Completed
• Trial end date: 2022-02-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SoVarGen Co., Ltd.
• Treatments: Everolimus

Criteria

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