Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | 13 subjects will receive
|
|
| Group II | Experimental | 13 subjects will receive
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SVG101 (T) | Drug | 5mg of SVG101 |
| |
| Afinitor (R) |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of everolimus | up to 144 hours | |
| Cmax of Everolimus | up to 144 hours | |
| Cmin,ss,pred of Everolimus | up to 144 hours | |
| AUClast of Everolimus | up to 144 hours | |
| Tmax of Everolimus | up to 144 hours | |
| t1/2 of Everolimus | up to 144 hours | |
| Vd/F of Everolimus | up to 144 hours | |
| Clearance of Everolimus | up to 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | up to approximately 45 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric J Maeng | Sovargen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Healthcare System, Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25799227 | Background | 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. |
| Label | URL |
|---|---|
| Everolimus\_Clinical Pharmacology Review | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
5mg of Afinitor |
|