NCT03818672

Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects

Open Label Study to Evaluate the Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy Subjects and Subjects With Severe Hepatic Impairment

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to characterize the steady state plasma

Detailed description

The primary objective of this study is to characterize the steady state plasma PK of rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD \>25), as well as healthy subjects with normal hepatic function.

Conditions

• Severe Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Rifaximin	Rifaximin 550 MG BID

Timeline

• Start date: 2019-01-29
• Primary completion: 2020-02-02
• Completion: 2020-02-02
• First posted: 2019-01-28
• Last updated: 2023-11-30
• Results posted: 2023-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study