Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
1期
已完成
NCT02326233
| 适应症 | Healthy |
|---|
| 分期 | 1期 |
|---|
| 申办方 | Samsung Bioepis Co., Ltd. |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 190 人 |
|---|
| 干预（药物） | Pen of SB5, PFS of SB5 |
|---|
| 开始日期 | 2015年6月 |
|---|
| 完成日期 | 2015年9月 |
|---|
| 结果公布日 | 2019年3月18日 |
|---|
摘要
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 |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。