Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644105
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women
Sponsor:
None
Organization:
None
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:
No
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 MP milk to plasma ratio was estimated through the area under the plasma and milk concentration-time curves AUC 6 and the infants exposure Relative Infant DoseRID 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 mothers 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None