Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
Phase 1
Completed
NCT02326233
| Condition | Healthy |
|---|
| Phase | Phase 1 |
|---|
| Sponsor | Samsung Bioepis Co., Ltd. |
|---|
| Status | Completed |
|---|
| Enrollment | 190 participants |
|---|
| Interventions | Pen of SB5, PFS of SB5 |
|---|
| Start date | Jun, 2015 |
|---|
| Completion date | Sep, 2015 |
|---|
| Results posted | Mar 18, 2019 |
|---|
Summary
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose · h·μg/mL
| Pen of SB5 | 2743.2 ± 1081.76 h·μg/mL |
|---|
| PFS of SB5 | 2503.3 ± 1043.69 h·μg/mL |
|---|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose · h·μg/mL
| Pen of SB5 | 2329.2 ± 733.30 h·μg/mL |
|---|
| PFS of SB5 | 2182.2 ± 724.98 h·μg/mL |
|---|
Maximum Serum Concentration (Cmax)
0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose · μg/mL
| Pen of SB5 | 3.803 ± 1.0697 μg/mL |
|---|
| PFS of SB5 | 3.673 ± 0.8810 μg/mL |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.