Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03483259 | To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers | PHASE1 | COMPLETED | 30 | — | — | Apr 2, 2018 | May 18, 2018 | Nov 13, 2018 | 1 | China |
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
Maximum observed concentration, occurring at Tmax.
The time at which maximum plasma concentration (Cmax) is observed.
The time required for the concentration of the drug to reach half of its original value.
This term represents the relationship between the bioavailability of a substance in two different media.
| Arm | Type | Description |
|---|---|---|
| Arm A-Sulfatinib T capsule | EXPERIMENTAL | The subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. |
| Arm B-Sulfatinib R capsule | EXPERIMENTAL | The subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd. |
| Name | Type | Description |
|---|---|---|
| Sulfatinib T capsule | DRUG | Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production. |
| Sulfatinib R capsule | DRUG | Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd. |
Inclusion Criteria: 1. Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol； 2. Age of 18-40 (inclusive), male healthy volunteers； 3. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as norm...