A randomized, three-period, single-dose crossover trial in healthy female volunteers to demonstrate bioequivalence of tafoxiparin following subcutaneous administration via syringe/needle in the abdomen, and via an auto-injector in the abdomen and thigh, respectively.
This research is a small study involving healthy women. It's designed to compare different ways of giving a medicine called tafoxiparin, which might be used to help with labour. The study wants to check if the medicine is absorbed into the body in the same way when injected with a normal needle and syringe into the tummy, versus using an auto-injector into either the tummy or the thigh. This is important to ensure that if the medicine is approved in the future, it works consistently no matter how it’s given, making it safe and effective for patients.
At a glance
What is this study about?
This study is a very early stage of research, often called a "Phase I" study. It’s all about understanding how a medicine called tafoxiparin behaves in the human body. In this case, researchers want to see if the body handles the medicine in the same way, regardless of how it's injected.
Specifically, they are comparing three different ways of giving the medicine: injecting it into the tummy using a standard needle and syringe, injecting it into the tummy using a special device called an auto-injector, and injecting it into the thigh using an auto-injector. This type of study, called a "bioequivalence" study, makes sure that if the medicine is given in different ways, it still delivers the right amount of drug to your body, just as effectively.
Even though the study mentions "Labour priming" as a condition, this particular study is focused on how the drug is absorbed, not on its effects during labour. It's a foundational step to make sure any future use of tafoxiparin is reliable and consistent for patients who might need it.
Key takeaways
- This study tests how a medicine called tafoxiparin is absorbed in healthy women.
- It compares injections given by needle/syringe and by an auto-injector in different body areas.
- This is an early stage (Phase I) study, not a treatment study.
- Participation involves multiple visits for injections and monitoring.
- You must be a healthy woman aged 18 or older to join.
- It helps ensure future consistency and safety of the medicine.
Who may be eligible?
To join this study, you must be a healthy woman aged 18 or older. There is no upper age limit, as long as you are otherwise healthy. Being "healthy" usually means you don't have any significant medical conditions that could affect the study results or put you at risk.
Because this is a study for healthy volunteers, you shouldn't have any serious ongoing illnesses or be taking medications that could interfere with the study drug. The researchers will carry out a thorough health check to make sure it's safe for you to take part.
They're specifically looking for healthy women because the medicine might eventually be used for conditions related to women's health, such as labour. This helps them understand the medicine's behaviour in the group it's intended for.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman?
- Are you at least 18 years old?
- Are you generally healthy?
- Do you not have any major ongoing medical conditions?
- Are you able to attend several study visits?
What does participation involve?
If you decide to take part, you would attend the study clinic for scheduled visits. During these visits, you would receive the tafoxiparin medicine as a single dose, switching between the different injection methods (syringe in tummy, auto-injector in tummy, auto-injector in thigh) over three separate periods. This means you would receive each injection method once.
Throughout the study, nurses and doctors would closely monitor you. This would involve regular blood tests to check how the medicine is absorbed and leaves your body, as well as checking your general health and looking for any side effects. You would be expected to follow specific instructions about what you can eat, drink, or do around the time of your study visits. The total duration of your involvement could span several weeks or months, as there would be washout periods between each different injection method.
Potential risks and benefits
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Common questions
What is tafoxiparin?
Tafoxiparin is a medicine being studied. This particular research is looking at how it's absorbed into the body when given in different ways.
What does 'bioequivalence' mean?
Bioequivalence means that two different ways of giving a medicine result in the same amount of the drug getting into your body at the same speed. It ensures consistency.
Will I receive different doses of the medicine?
No, you will receive a single dose of tafoxiparin at each study period, but the way it's given (injection method and location) will change. The dose itself remains the same.
Is this study meant to treat a condition?
No, this is a Phase I study focused on how the drug is absorbed in healthy women, not on treating any medical condition. It's an early step in drug development.
How long will I need to be in the study?
The study involves several separate periods of participation, with breaks in between. The full duration of your involvement, from start to finish, would be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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