A Study Comparing How the Body Absorbs Cefixime in Healthy Volunteers

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What is this study about?

This study involves healthy people rather than those with a specific disease. The study will compare two medicines that both contain the antibiotic cefixime. One medicine is called Cefixima Atb 400mg and comes as hard capsules, while the other is called Cefixoral 400mg and comes as coated tablets. Both medicines contain the same amount of the active ingredient but are made by different companies and have different forms.

The purpose of the study is to see if the body absorbs the two medicines in the same way and at the same speed when people take a single dose of 400mg without eating. This type of study is called a bioequivalence study. During the study, participants will receive one of the two medicines and then, after a break period, they will receive the other medicine. Blood samples will be taken to measure how much of the medicine is in the blood and how long it stays in the body.

The study will also check for any unwanted effects or side effects that might happen after taking the medicines. This includes monitoring any health problems that occur, changes in blood pressure and heart rate, and results from blood and urine tests. The information gathered will help determine if the two medicines work in the same way in the body.

1 First treatment period

You will receive a single dose of one of the study medications containing 400 mg of cefixime. This will be either CEFIXIMA ATB 400 mg hard capsules or CEFIXORAL 400 mg film coated tablets.

The medication will be taken by mouth in a fasting state, which means you should not have eaten before taking it.

After taking the medication, blood samples will be collected at specific times to measure how the drug is absorbed and processed by your body. These measurements include how much of the drug reaches your bloodstream and how quickly this happens.

2 Washout period between treatments

There will be a break between the two treatment periods. This time allows the first medication to be completely eliminated from your body before you receive the second one.

3 Second treatment period

You will receive a single dose of the other study medication containing 400 mg of cefixime. If you received CEFIXIMA ATB 400 mg hard capsules in the first period, you will now receive CEFIXORAL 400 mg film coated tablets, or vice versa.

The medication will be taken by mouth in a fasting state.

After taking the medication, blood samples will be collected again at specific times to measure how this drug is absorbed and processed by your body.

4 Safety monitoring throughout the study

Throughout the study, your safety will be monitored. This includes checking for any side effects or unwanted reactions to the medications.

Your vital signs will be measured, including blood pressure and heart rate.

Standard laboratory tests will be performed to check your blood and urine.

Who Can Join the Study?

You must provide your agreement to participate in the study by signing a written informed consent form, which is a document that explains the study details and confirms you agree to take part, before any other study procedures begin
You must be Caucasian, which refers to a specific racial group, and can be either male or female
You must be between 18 and 55 years old
Your Body Mass Index, which is a measure calculated from your height and weight to assess if you have a healthy body size, must be between 18.5 and 30 kg/m2
You must be a non-smoker or a light smoker, meaning you smoke less than 10 cigarettes per day
Your physical examination, which is a general check-up of your body, must show normal results at the beginning of the study
Your blood pressure, which is the force of blood against your artery walls, must be between 100-140 mmHg for the upper number and 60-90 mmHg for the lower number, and your heart rate, which is how many times your heart beats per minute, must be between 50-90 beats per minute when measured while you are lying down after resting for 5 minutes
Your ECG, which is a test that records the electrical activity of your heart, must show normal results or changes that are not medically concerning at the beginning of the study
Your blood tests, including hematology which checks your blood cells, clinical chemistry which measures substances in your blood, and urinalysis which examines your urine, must show normal results or changes that are not medically concerning at the beginning of the study
If you are female, you must have a negative serum beta-HCG test, which is a blood test that checks if you are pregnant
You must be able to understand the complete nature and purpose of the study, including any possible risks and side effects
You must be able to swallow the study medication
You must be able to cooperate with the study doctor and follow all study requirements completely
You must be enrolled in a social security system or have health insurance, or be someone who receives benefits from such a system

Who Cannot Join the Study?

Pregnant women – women who are expecting a baby cannot take part in this study
Breastfeeding women – women who are nursing a baby cannot participate
People with known allergies or hypersensitivity (a strong reaction by the body’s defense system) to cefixime (the medicine being tested), other similar antibiotics called cephalosporins, or penicillins
People with a history of severe allergic reactions to any medication
People with kidney disease or problems with how their kidneys work
People with liver disease or problems with how their liver works
People with diseases of the digestive system (the organs that process food), especially conditions affecting the intestines (bowels)
People with a history of gastrointestinal bleeding (bleeding in the stomach or intestines)
People who have had colitis (inflammation of the large intestine) in the past
People taking certain other medications that could interfere with the study
People who have donated blood within a certain time period before the study
People who have participated in another clinical trial recently
People who smoke heavily or use tobacco products
People who consume alcohol regularly or use drugs
People with any serious medical condition that could affect their safety during the study
People who cannot follow the study requirements or attend all scheduled visits

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Atlsdgsngkk Svgs	Iasi	Romania

Trial status

Country	Status	Recruitment Start
Romania	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

CEFIXIMA ATB is an antibiotic medication that comes in the form of hard capsules. It is used to treat bacterial infections by stopping the growth of bacteria in the body. In this study, it is being tested to see how well the body absorbs it compared to another similar medication.

CEFIXORAL is also an antibiotic medication that comes in the form of film coated tablets. It works in the same way as CEFIXIMA ATB by fighting bacterial infections. This medication is being used as the comparison product in the study to see if both medications work similarly in the body.

Healthy Subjects – This study involves healthy subjects, meaning individuals who do not have any disease or medical condition. Healthy subjects are people with normal physical and mental health who volunteer to participate in clinical research. They have no active illnesses, infections, or chronic conditions that would affect the study results. These participants help researchers understand how medications work in the body under normal conditions. Healthy subjects typically have normal organ function and are not taking medications that could interfere with the study. Their participation provides baseline data for comparing how drugs behave in people without underlying health problems.

Trial ID:

2023-504011-33-00

Protocol code:

CEFIAIS 01/2022

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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A Study Comparing How the Body Absorbs Cefixime in Healthy Volunteers

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