Trials / Completed
CompletedNCT04676035
The DDI Study Had Been Designed to Investigate the Effect of SHR3680 on the Pharmacokinetics of Midazolam, S-Warfarin and Omeprazole
A Single-center, Open-label, Fixed-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of SHR3680 With Midazolam （CYP3A4 Substrates), S-Warfarin (CYP2C9 Substrates) and Omeprazole (CYP2C19 Substrates) in Prostate Cancer Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Male
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of Midazolam, S-Warfarin and Omeprazole
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680 | * Experimental: Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680 * Midazolam, Warfarin, Omeprazole and VitaminK1 QD on Day 1 and Day 22, SHR3680 240 mg once daily (QD) from Study Day 6 - 27 |
Timeline
- Start date
- 2020-06-15
- Primary completion
- 2022-01-26
- Completion
- 2022-01-26
- First posted
- 2020-12-19
- Last updated
- 2023-02-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04676035. Inclusion in this directory is not an endorsement.