Evaluate the Pharmacokinetics of Warfarin When Coadministered With PEX168 in Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT02461914|
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : January 24, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: PEX168 Drug: Warfarin||Phase 1|
This was an open-label, sequential, single-center study that evaluated the pharmacokinetics of warfarin when coadministered with PEX168 in healthy adult subjects. The total duration of each subject's participation in the study was approximately 13 weeks, which included up to a 14-day Screening Period, a 51-day Treatment Period, and an approximately 4-week Follow-up Period.
Center: This study was conducted at a single site in the first affiliate hospital of Zhejiang University.All subjects receives a single 5mg oral dose of warfarin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 8 and a second single 5mg oral dose of warfarin on Day 44.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects|
|Actual Study Start Date :||August 1, 2015|
|Actual Primary Completion Date :||December 12, 2015|
|Actual Study Completion Date :||July 13, 2016|
Experimental: Warfaring and PEX168(200µg)
Warfarin: 5mg, oral Administration. PEX 168: 200µg,injected subcutaneously,once a week.
200µg,injected subcutaneously,once a week.
Other Name: Polyethylene Glycol Loxenatide
Other Name: Warfarin sodium tablets
- Composite measure the plasma concentrations of warfarin [ Time Frame: Baseline to Day51 ]Plasma concentrations of warfarin, and to calculate the pharmacokinetic parameters: Tmax、Cmax、AUC0-t、AUC0-∞、λz ，t1/2、Vd/F、CL/F etc.
- Incidence of adverse events and serious adverse events [ Time Frame: Baseline to Day78 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461914
|Principal Investigator:||Jianzhong Shentu, MD||The first affiliate of Zhejiang University|