NCT04006353

The Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects

A Phase 4, Single-center, Open-label, Parallel Study to Evaluate the Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shanghai Public Health Clinical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to estimate the drug interaction between RIF and ABT. This will be a single-center, open-label, parallel study in healthy adult subjects.

Detailed description

The purpose of this study is to describe and compare RIF and ABT pharmacokinetics following administration of 320mg ABT and 600mg RIF.12 subjects will receive 320mg ABT on Days 1、2、3、8 (Treatment 1). And 12 subjects will receive 600mg RIF daily for 16 days from Day 1 to 16, and receive 320mg ABT on Days 7、8、9 and 14 (Treatment 2).

Conditions

• Drug Interaction

Interventions

Type	Name	Description
DRUG	ABT	320 mg, Intravenous infusion
DRUG	RIF	600mg q.d.

Timeline

• Start date: 2019-07-11
• Primary completion: 2019-09-30
• Completion: 2019-12-03
• First posted: 2019-07-05
• Last updated: 2021-09-24

Locations

1 site across 1 country: China