Trials / Completed
CompletedNCT02815774
SP2086 Pharmacokinetic Study in Renal Insufficiency Patients
A Parallel, Open Phase Ih Study to Access the Pharmacokinetic of SP2086 in Renal Insufficiency Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to investigate the SP2086 pharmacokinetic in Renal Insufficiency Patients.
Detailed description
This trial adopt in a parallel, open, single dose study design. The subject was divided into one of five groups according to the degree of renal Insufficiency, which including normal, mild, moderate, severe, and end-stage. All subjects were given SP2086 50mg, and collected the blood samples before and after the medicine taken.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SP2086 | all subjects were given SP2086 50mg only one time. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2016-06-28
- Last updated
- 2016-06-28
Source: ClinicalTrials.gov record NCT02815774. Inclusion in this directory is not an endorsement.