Medication SafetyRIDNCT06644105
Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women
A study testing cefditoren pivoxil tablets in people with Medication Safety and Drug Safety, run by West China Second University Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medication Safety, Drug Safety, Drug Metabolism
- What is being tested?
- cefditoren pivoxil tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
- Positive drug abuse screening, or a history of drug abuse within the past five years, or use of drugs within 3 months before screening, or positive urine drug screening results
- Regular alcohol consumption within 3 months before screening, i.e., more than 2 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content), and/or unwilling to abstain from alcohol intake 48 hours before and during the hospital stay
- An average daily smoking amount of more than 5 cigarettes within 3 months before screening, and/or unwilling to avoid the use of any tobacco products during the trial period
- Consumption of any food or beverages rich in caffeine, poppy seeds and/or theophylline, theobromine, cocoa (such as coffee, strong tea, chocolate, and caffeinated carbonated beverages, cola, etc.) within 48 hours before taking the study medication, or consumption of any food or beverages rich in grapefruit (such as grapefruit juice) within 48 hours before taking the study medication, or engaging in vigorous exercise
- Subjects who may not be able to complete the study for other reasons, or whom the researcher judges to have other reasons not suitable for participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- cefditoren pivoxil tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefditoren pivoxil tabletsDrug
took cefditoren pivoxil tablets 200mg after
| Study group | Role | What they receive |
|---|---|---|
| subjects took cefditoren pivoxil tablets 200mg after a meal | Experimental | take cefditoren pivoxil tablets 200mg after a meal Receives: Drug: cefditoren pivoxil tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 12 hours after taking the medication
the milk-to-plasma ratio
milk to plasma ratio
Measured: within 12 hours after taking the medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start10 Jan 2024
- Primary completion24 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Qin, West China Second University Hospital
- Investigators
- Qin yu, Principal investigator, National Drug Clinical Trial Institution of West China Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644105
- Sponsor's protocol ID
- 2024004-TBTLPZ
- Acronym
- RID
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women
- ClinicalTrials.gov ID
- NCT06644105
- Acronym / sponsor ID
- RID / 2024004-TBTLPZ
- Conditions
- Medication Safety, Drug Safety, Drug Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects took cefditoren pivoxil tablets 200mg after a meal | Experimental | Drug: cefditoren pivoxil tabletstake cefditoren pivoxil tablets 200mg after a meal |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefditoren pivoxil tabletstook cefditoren pivoxil tablets 200mg after | Drug | subjects took cefditoren pivoxil tablets 200mg after a meal |
Primary outcome
the relative infant dose
Time frame: within 12 hours after taking the medication
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
the milk-to-plasma ratio
Time frame: within 12 hours after taking the medication
milk to plasma ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qin yu principal investigator
National Drug Clinical Trial Institution of West China Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cefditoren pivoxil tablets in people with Medication Safety and Drug Safety, run by West China Second University Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the relative infant dose (time frame: within 12 hours after taking the medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.