A Study Comparing How the Body Absorbs Cefixime in Healthy Volunteers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
14 criteria
- 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 trial?
16 criteria
- 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
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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.
What is already known about the treatment
CEFIXIMA ATB
This medication is a hard capsule containing 400 mg of cefixime, an antibiotic that belongs to a class of drugs called cephalosporins, which are used to treat various bacterial infections. Cefixime works by interfering with the formation of the bacterial cell wall, causing the wall to break down and ultimately killing the bacteria. This formulation is taken by mouth and is being studied in clinical trials to compare how well the body absorbs it compared to another cefixime product already on the market. The study is being conducted in healthy volunteers to ensure the medication meets the required standards for effectiveness and safety.
CEFIXORAL
This is a film-coated tablet containing 400 mg of cefixime, which is an antibiotic medication used to fight bacterial infections in the body. It works by blocking the bacteria's ability to build their protective outer wall, which causes them to die and helps clear the infection. This medication is taken orally and is already approved and available in the market as a reference treatment. In this clinical trial, it serves as the comparison product to evaluate whether a newer version of cefixime works similarly in the body.
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
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