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

SoVarGen

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: SVG101 (T); Drug: Afinitor (R)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05490095

SVG101-P1-01

Details and patient eligibility

About

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 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.

Enrollment: 26 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Group I

Experimental group

Description:

13 subjects will receive 1. First Dose: Afinitor 5mg, single dose 2. Wash out period : more than 10 days 3. Second Dose: SVG101 5mg, single dose

Treatment:

Drug: Afinitor (R)

Drug: SVG101 (T)

Group II

Experimental group

Description:

13 subjects will receive 1. First Dose: SVG101 5mg, single dose 2. Wash out period : more than 10 days 3. Second Dose: Afinitor 5mg, single dose

Treatment:

Drug: Afinitor (R)

Drug: SVG101 (T)