NCT02461914

Evaluate the Pharmacokinetics of Warfarin When Coadministered With PEX168 in Healthy Adult Subjects

An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PEX168	200µg,injected subcutaneously,once a week.
DRUG	Warfarin	5mg,oral,two times.

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-12-12
• Completion: 2016-07-13
• First posted: 2015-06-03
• Last updated: 2017-01-24