Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT06644105
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2024-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women
Sponsor:
West China Second University Hospital
Organization:
Study Overview
Official Title:
Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RID
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: