Evaluate the Pharmacokinetics of Warfarin When Coadministered With PEX168 in Healthy Adult Subjects
NCT02461914 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2017-01-24
Summary
To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy subjects.To provide a scientific basis for clinical drug combination of PEX168.
To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin in healthy subjects.
To assess the safety of single doses of warfarin administered with and without PEX168
Conditions
- Healthy
Interventions
- DRUG
-
PEX168
200µg,injected subcutaneously,once a week.
- DRUG
-
Warfarin
5mg,oral,two times.
Sponsors & Collaborators
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianzhong Shentu, MD · The first affiliate of Zhejiang University
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-08-01
- Primary Completion
- 2015-12-12
- Completion
- 2016-07-13
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