Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT06644105
Brief 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 Doseļ¼RID) 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.
Study:
NCT06644105
Study Brief:
Protocol Section:
NCT06644105