Trials / Completed
CompletedNCT04989829
Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
A Single-centre, One-arm, Open-label, Fixed-sequence Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Male and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in absence and presence of prior administration of proton pump inhibitor Omeprazole. The increased gastric pH achieved by the treatment with multiple doses of Omeprazole might affect the absorption process of SHR6390.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR6390、Omeprazole | SHR6390 tablet single dose、Omeprazol single dose. |
Timeline
- Start date
- 2021-12-27
- Primary completion
- 2022-01-26
- Completion
- 2022-02-14
- First posted
- 2021-08-04
- Last updated
- 2023-06-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04989829. Inclusion in this directory is not an endorsement.