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

NCT06644105 | Completed

• 1 other identifier: 2024004-TBTLPZ
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Safety; Drug Safety; Drug Metabolism

Outcome Measures

Primary Outcomes (2)

• the relative infant dose

  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

  within 12 hours after taking the medication

• the milk-to-plasma ratio

  milk to plasma ratio

  within 12 hours after taking the medication

Study Arms (1)

subjects took cefditoren pivoxil tablets 200mg after a meal

EXPERIMENTAL

take cefditoren pivoxil tablets 200mg after a meal

Drug: cefditoren pivoxil tablets

Interventions

cefditoren pivoxil tablets DRUG

took cefditoren pivoxil tablets 200mg after

subjects took cefditoren pivoxil tablets 200mg after a meal

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Lactating women, aged 25-45 years (inclusive) at the time of informed consent
• Body Mass Index (BMI) of 19 to 28 kg/m\^2 (inclusive)
• weight not less than 45.0 kg
• Physical examination results including vital signs (blood pressure, pulse, and body temperature), physical examination, laboratory tests (complete blood count, blood biochemistry, and urine routine), and 12-lead ECG are all normal or the abnormalities are not clinically significant
• The subject has no plans for pregnancy or oocyte donation from the time of signing the informed consent until 3 months after the end of the trial, and is willing to take effective contraceptive measures
• The subject is able to communicate well with the researcher and understands and is able to comply with the requirements of this study.

You may not qualify if:

• Individuals found during screening to have clinically significant diseases (including but not limited to respiratory, circulatory, cardiovascular, digestive, hematological, endocrine, immune, skin, nervous system, carnitine deficiency, or congenital metabolic defects that can cause significant carnitine deficiency, and related diseases)
• Those with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as those allergic to two or more drugs, foods), or known to be allergic to any component of cefditoren pivoxil tablets, especially the cephalosporin antibiotics and excipients
• Acute diseases occurring from the screening period to before the study medication or concomitant medication use
• Received surgical procedures (cesarean section excluded) within 3 months before screening, or planning to undergo surgical procedures during the study period
• Abnormalities of clinical significance judged by a clinical physician based on comprehensive physical examination, ECG, vital signs, and laboratory tests (complete blood count, coagulation function, blood biochemistry, urine routine, pre-transfusion panel) during the screening period
• Positive results in any of the tests for hepatitis B surface antigen (TP-trust), hepatitis C virus antibody, anti-human immunodeficiency virus antibody, or syphilis spirochete antibody
• Use of any drugs that may interact with the test drug within 30 days before the first administration, including CYP3A4 inhibitors and inducers (such as inducers-barbiturates, carbamazepine, phenytoin, rifampicin, etc.
• inhibitors-SSRI class antidepressants, cimetidine, cyclosporine, macrolides, verapamil, fluoroquinolones, pyrrolidine antifungal drugs, HIV protease inhibitors, etc.), CYP2C9 inhibitors and inducers (such as inhibitors-sulfamethoxazole, amiodarone, fluconazole, metronidazole, prednisone, etc.
• inducers-apalutamide, darunavir, enzalutamide, letermovir, nevirapine, secobarbital, St. John's wort, etc.), antacids (such as omeprazole, rabeprazole, pantoprazole, ranitidine, famotidine, aluminum hydroxide, magnesium hydroxide, or sucralfate) and other drugs
• Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicine, or health products within 2 weeks before taking the study medication
• Blood donation or significant blood loss (\>400 mL), blood transfusion, or use of blood products within 3 months before screening
• Received live or attenuated vaccines within 1 month before screening, or planning to receive live or attenuated vaccines during the trial period
• Participated in any medical device clinical trials or drug clinical trials and used trial medical devices and/or drugs within 3 months before screening
• Intolerant to venipuncture, fainting at the sight of blood or needles, or poor venous access for blood collection
• Having special dietary requirements, lactose intolerance, inability to comply with the provided diet and corresponding regulations, or difficulty swallowing pills

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital

Chengdu, China

Location

MeSH Terms

Interventions

cefditoren pivoxil

Study Officials

• Qin yu

  National Drug Clinical Trial Institution of West China Second Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 16, 2024
• Study Start: January 10, 2024
• Primary Completion: January 24, 2024
• Study Completion: March 1, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

CN (1)