NCT07457190

Pharmacokinetic Study of Buagafuran Capsules in Participants With Hepatic Impairment and Normal Hepatic Function

Pharmacokinetic and Safety Study of Buagafuran Capsules in Participants With Hepatic Impairment and Normal Hepatic Function

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Beijing Union Pharmaceutical Factory Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment.

Detailed description

This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment. This study enrolled 24 participants, both male and female. Three experimental groups were set up, with Day1 taking 30 mg Buagafuran capsules on an empty stomach in the morning.Participants can leave on Day3.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Buagafuran	participants to receive Buagafuran capsules 30 mg on an empty stomach on the morning of Day1

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2026-03-09
• Last updated: 2026-03-10

Locations

1 site across 1 country: China