Clinical TrialID 5543
The DDI Study Had Been Designed to Investigate the Effect of SHR3680 on the Pharmacokinetics of Midazolam, S-Warfarin and Omeprazole
NCT04676035
Prostate Cancer Patients
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5543
- Evidence Id
- 5543
- Core Evidence Id
- 5543
- Source Clinical Trial Id
- 5525
- Herb2 Clinical Trial Id
- HBCT005525
- Nct Id
- NCT04676035
- Title
- The DDI Study Had Been Designed to Investigate the Effect of SHR3680 on the Pharmacokinetics of Midazolam, S-Warfarin and Omeprazole
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Prostate Cancer Patients
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Basic_Science
- Gender
- Male
- Age
- Adult, Older_Adult
- Enrollment
- 18
- Outcome Measure
- Pharmacokinetics parameters of Midazolam, S-Warfarin and Omeprazole, Peak Plasma Concentration (Cmax), Day1 and Day22|Pharmacokinetics parameters of Midazolam, S-Warfarin and Omeprazole, Area under the plasma concentration versus time curve (AUC), Day1 and Day22
- Sponsor Collaborator
- Jiangsu HengRui Medicine Co., Ltd.
- Funded By
- INDUSTRY
- Location
- Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, China
- Other Id
- SHR3680-I-DDI-01
- Start Date
- 2020-06-15
- Primary Completion Date
- 2022-01-26
- Completion Date
- 2022-01-26
- First Posted
- 2020-12-19
- Results First Posted
- Last Update Posted
- 2023-02-09
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04676035
- Title Cn
- Title En
- The DDI Study Had Been Designed to Investigate the Effect of SHR3680 on the Pharmacokinetics of Midazolam, S-Warfarin and Omeprazole
- Bilingual Status
- semi_complete