NCT04444011

Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth

A Single-center, Randomized, Open-label, Crossover Study to Evaluate the Pharmacokinetic Drug-drug Interaction of the Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth in Healthy Chinese Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

A single-center, randomized, open-label, crossover study to evaluate the pharmacokinetic drug-drug interaction and safety of the quadruple therapy with Anaprazole 20mg/Amoxicilin 1000mg/Clarithromycin 500mg/Bismuth Potassium Citrate 0.6g in healthy Chinese male subjects.

Detailed description

The study composed of 2 cohorts, using a 4\*4 or 2\*2 crossover design in cohort 1 and 2, respectively. 4 rotating treatment sequences in cohort 1, each treatment sequence comprised 4 treatment periods, separated by a washout period of 9 days; 2 rotating treatment sequences in cohort 2, each treatment sequence comprised 2 treatment periods, separated by a washout period of 9 days

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Anaprazole Sodium	Anaprazole Sodium isthePPI inhibitor
DRUG	Amoxicillin	antibiotic
DRUG	Clarithromycin	antibiotic
DRUG	Bismuth	Bismuth is to protect the gastric mucosa

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-09-30
• Completion: 2020-10-15
• First posted: 2020-06-23
• Last updated: 2020-06-23