Trials / Completed
CompletedNCT05354336
A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers
A Randomized, Open-Label, Phase I Clinical Study on SHR6390 of Different Specifications After Process Modification in Healthy Chinese Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- The Affiliated Hospital of Qingdao University · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR6390(100mg) | SHR6390 at a single oral dose of 100 mg. |
| DRUG | SHR6390(125mg) | SHR6390 at a single oral dose of 125 mg. |
| DRUG | SHR6390(150mg) | SHR6390 at a single oral dose of 150 mg. |
Timeline
- Start date
- 2019-06-13
- Primary completion
- 2019-08-24
- Completion
- 2019-08-24
- First posted
- 2022-04-29
- Last updated
- 2022-05-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05354336. Inclusion in this directory is not an endorsement.