NCT07294846

Drug Interaction Study on Linaprazan Glurate Capsules

Drug Interaction Study on Linaprazan Glurate Capsules, Clarithromycin Tablets, Amoxicillin Capsules, and Bismuth Potassium Citrate Capsules

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a drug-drug interaction (DDI) investigation involving Linaprazan Glurate capsules and a combination of clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules. The study plan is divided into two parts: one involving Hp-negative healthy subjects and the other involving Hp-positive subjects.

Detailed description

The first part of the study is designed as a single-center, randomized, open-label, four-period, four-sequence crossover trial to evaluate the changes in pharmacokinetic (PK) profiles of Linaprazan Glurate capsules when co-administered with clarithromycin tablets and amoxicillin capsules compared to their individual administration, as well as the safety and tolerability of the combination therapy in Hp-negative healthy adult Chinese subjects. The second part of the study is designed as a single-center, randomized, open-label, parallel-group, positive-controlled trial to compare the differences in systemic exposure of bismuth potassium citrate capsules between the Linaprazan Glurate capsule-based quadruple therapy (combined with clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules) and the esomeprazole magnesium enteric-coated tablet-based quadruple therapy (combined with clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules), to evaluate the pharmacodynamic effects on intragastric pH, to assess the safety and tolerability of the Linaprazan Glurate capsule-based quadruple therapy, and to preliminarily explore its efficacy in eradicating Helicobacter pylori (Hp) in Hp-positive subjects.

Conditions

• Healthy Volunteers
• Patients

Interventions

Type	Name	Description
DRUG	Linaprazan Glurate Capsules	Linaprazan Glurate capsules
DRUG	Bismuth Potassium Citrate Capsules	Bismuth Potassium Citrate Capsules
DRUG	Amoxicillin Capsules	Amoxicillin Capsules
DRUG	Clarithromycin tablets	Clarithromycin Tablets
DRUG	Esomeprazole Magnesium Enteric-coated Tablets	Esomeprazole Magnesium Enteric-coated Tablets

Timeline

• Start date: 2025-09-08
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2025-12-19
• Last updated: 2026-01-06

Locations

1 site across 1 country: China