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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-23

Study Completion Date

2022-02-07

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

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

Group Type EXPERIMENTAL

SVG101 (T)

Intervention Type DRUG

5mg of SVG101

Afinitor (R)

Intervention Type DRUG

5mg of Afinitor

Group II

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

Group Type EXPERIMENTAL

SVG101 (T)

Intervention Type DRUG

5mg of SVG101

Afinitor (R)

Intervention Type DRUG

5mg of Afinitor

Interventions

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SVG101 (T)

5mg of SVG101

Intervention Type DRUG

Afinitor (R)

5mg of Afinitor

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes