NCT06644105

Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: West China Second University Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to provide a theoretical basis for the rational use of cefditoren pivoxil in lactating women by conducting a pharmacokinetic study of cefditoren in the blood and milk of these women. The main questions it aims to answer are: Can lactating women use cefditoren pivoxil? Is cefditoren distributed in breast milk? 12 Participants will: Take cefditoren pivoxil tablets 200mg after a meal, and collect breast milk and plasma over certain time periods.

Detailed description

This study is a single-center, single-sequence, open-label pharmacokinetic study involving Chinese healthy lactating subjects. It aims to investigate the exposure of cefditoren in blood and milk in lactating women. The M/P (milk to plasma) ratio was estimated through the area under the plasma and milk concentration-time curves (AUC) \[6\], and the infant's exposure (Relative Infant Dose，RID) was estimated as the product of the actual milk production and the average milk drug concentration, normalized by body weight and expressed as a percentage of the mother's dose adjusted for body weight. By studying the pharmacokinetics of cefditoren in blood and milk, the study provides a theoretical basis for the rational use of cefditoren pivoxil in lactating women.

Conditions

• Medication Safety
• Drug Safety
• Drug Metabolism

Interventions

Type	Name	Description
DRUG	cefditoren pivoxil tablets	took cefditoren pivoxil tablets 200mg after

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-01-24
• Completion: 2024-03-01
• First posted: 2024-10-16
• Last updated: 2024-10-16

Locations

1 site across 1 country: China