drugset / Trial / NCT04810533
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
NaSingle-groupOpen-labelOther
Summary
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] SH-1028 in healthy Chinese male subjects. The study will be conducted into two steps:Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the collection time of plasma, urine and feces sampling post-dose. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 2-4 subjects will be adjusted according to the pilot study.
Timeline
- Start
- 2020-05-13
- Primary completion
- 2021-03-05
- Completion
- 2021-03-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ORITINIB | Small molecule | 200 mg | Oral |
Indications
No indication recorded.