NCT02472236

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

An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Digoxin 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 digoxin in healthy subjects.To provide a scientific basis for clinical drug combination of PEX168. To assess the safety of single doses of digoxin administered with and without PEX168

Detailed description

This was an open-label, sequential, single-center study that evaluated the pharmacokinetics of digoxin when coadministered with PEX168 in healthy adult subjects. The total duration of each subject's participation in the study was approximately 12 weeks, which included up to a 14-day Screening Period, a 44-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 Xi'an Jiaotong University.All subjects receives a single 0.5mg oral dose of digoxin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 8 and a second single 0.5mg oral dose of digoxin on Day 38.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PEX168	200µg,injected subcutaneously,once a week.
DRUG	Digoxin	0.5mg,oral,two times.

Timeline

• Start date: 2015-06-08
• Primary completion: 2015-09-24
• Completion: 2016-01-18
• First posted: 2015-06-15
• Last updated: 2017-01-24

Locations

1 site across 1 country: China