HELP CLINICAL RESEARCH TODAY
We are looking for healthy males or females aged between 18 and 50, that may be eligible to participate in a clinical trial investigating a new type of formulation being developed for the treatment of sickle cell disease.
Maximum inconvenience payment of £1720.
Simbec-Orion Clinical Pharmacology will soon be running a study to investigate hydroxycarbamide in 2 different forms: hydroxycarbamide oral dispersible tablets (test product) in comparison with a hydroxycarbamide Siklos® oral film-coated tablet (reference product).
The main objectives of this study are as follows:
- To investigate the concentration of hydroxycarbamide oral dispersible tablets (test product) in the blood, how this concentration changes over a period of time and to evaluate whether there are differences in the concentration of hydroxycarbamide in the blood between the hydroxycarbamide oral dispersible tablets (test product) and the hydroxycarbamide Siklos® oral film-coated tablet (reference product).
- To evaluate the bioequivalence (assessment of whether products can be considered the same in terms of effect) of hydroxycarbamide as an oral dispersible tablet (test product) in comparison with the hydroxycarbamide Siklos® oral film-coated tablet (reference product).
- To determine the safety and tolerability (extent to which side effects of a drug can be tolerated) of hydroxycarbamide oral dispersible tablets (test product) in comparison with a hydroxycarbamide Siklos® oral film-coated tablet (reference product) when they are administered as a single dose of 1000 milligrams (mg).
Hydroxycarbamide is a marketed product which is used for the treatment of a group of red blood cell diseases known as sickle cell disease. Hydroxycarbamide is currently only available in the form of oral tablets/capsules to swallow or in the form of a solution which can be swallowed. As sickle cell is a lifelong condition, these forms of hydroxycarbamide are not always best suited for administration in children or in individuals who may have difficulties in swallowing tablets and therefore, there is an unmet need to develop potential new forms of hydroxycarbamide in alternative dosage forms which could be more suitable for these populations without affecting the effectiveness of the treatment.
The study will consist of 3 planned groups of 10 participants: with participants in each group receiving both the test and the reference product across 2 treatment periods at the same dose strength (1000 mg). In this study, participants will be given hydroxycarbamide in 2 different forms: the test product as a hydroxycarbamide oral dispersible tablet (to be dissolved in water) and the reference product (hydroxycarbamide Siklos® oral film-coated tablet) as an oral tablet (to be swallowed with water).
Blood samples will be taken at set time points throughout the study in order to measure the concentration of hydroxycarbamide in the blood. We will compare the results between the test and reference product to determine if there are any significant differences in the safety of hydroxycarbamide, the concentration of hydroxycarbamide in the blood, how this concentration changes over time and whether the way in which the hydroxycarbamide is administered has any significant impact on these factors.
The purpose of the data generated in this study is to provide important information which will go on to support drug marketing applications for the test product so that this new form of hydroxycarbamide may be marketed as an alternative dosage form to the currently available hydroxycarbamide products.
If you participate in this study, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 3 days (2 overnight stays) per treatment period followed by a post study follow-up visit 1-3 days after the last dose of hydroxycarbamide. The 2 treatment periods will be separated by a minimum period of 3 days (72 hours) and you should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this study.
If you complete this study, you will receive a maximum inconvenience payment of £1720.
Thank you for your interest in joining our panel of healthy volunteers, please register by completing the below form.