NCT07330531

Drug-drug Interaction Study of Rifampin and Anaprazole Sodium

A Drug-drug Interaction Study to Evaluate the Effects of Rifampin Capsules on the Pharmacokinetics of Anaprazole Sodium Enteric-coated Tablets in Healthy Adult Subjects

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A drug-drug interaction study designed to evaluate the drug-drug interaction between rifampin capsules and anaprazole sodium enteric-coated tablets in healthy adult subjects

Detailed description

This is an open-label, single-center, two-period, single-sequence crossover drug-drug interaction study of rifampin capsules and anaprazole sodium enteric-coated tablets in healthy adult subjects. On Day 1 and Day 10, subjects will orally receive a single 60 mg dose of anaprazole sodium enteric-coated tablets in the morning under fasting conditions. From Day 4 to Day 11, subjects will orally receive 600 mg of rifampin capsules once daily (QD) in the morning under fasting conditions for 8 consecutive days. Specifically, on Day 10, subjects will orally receive both a single 60 mg dose of anaprazole sodium enteric-coated tablets and a 600 mg dose of rifampin capsules in the morning under fasting conditions. Pharmacokinetics will be followed from Day 1 through Day 12.

Conditions

• Drug-drug Interaction Study

Interventions

Type	Name	Description
DRUG	Anelazol Sodium Enteric-coated Tablets	60mg QD
DRUG	Rifampicin Capsules	600mg QD

Timeline

• Start date: 2026-01-04
• Primary completion: 2026-02-05
• Completion: 2027-07-21
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: China