A study to compare hydroxycarbamide oral solution and hard capsules
Research type
Research Study
Full title
A SINGLE CENTRE, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, THREE-PERIOD CROSSOVER STUDY TO ASSESS THE BIOEQUIVALENCE OF AN ORAL HYDROXYCARBAMIDE SOLUTION 500 mg / 5 mL VERSUS TWO FORMULATIONS OF ORAL HYDROXYCARBAMIDE CAPSULE 500mg (Hydrea®) IN HEALTHY ADULT SUBJECTS UNDER FASTING CONDITIONS.
IRAS ID
214422
Contact name
Annelize Koch
Contact email
Sponsor organisation
Nova Laboratories
Eudract number
2016-003765-25
Duration of Study in the UK
0 years, 1 months, 9 days
Research summary
This study is to help the development of a drug called Hydroxycarbamide 500 mg/5 mL Oral solution for the treatment of children and adults with sickle cell anaemia (SCA). The purpose of this study is show that the test product is bioequivalent to a both the European and American reference products (i.e. it contains the same active pharmaceutical ingredient and behave similarly within the body).
Hydroxycarbamide was approved for the treatment of adults with SCA by the Food and Drug Administration (FDA) in 1997, and for both children and adults by the European Medicines Agency (EMA) in 2006. Hydrea ® 500 mg capsules are indicated for the treatment of certain cancers, such as chronic myeloid leukaemia.
In this study we will recruit 30 subjects; each subject will take part in 3 treatment periods. At each treatment period the subject will receive one of the following products:
• Hydroxycarbamide 500 mg/5 mL Oral solution (the new medication being tested)
• Hydrea® Hard Capsule (marketed European (EU) product)
• Hydrea® Hard Capsule (marketed US product)
There will be washout period of at least 3 days before the subject takes part in the next treatment period. This is to ensure the drug has cleared the body. This type of study design (Crossover study) therefore allows us to compare how each of the three drugs listed above in individual subject.The key objective is to analyse the pharmacokinetic (PK) parameters of the test drug compared against the two reference products. The PK parameters will include seeing how quickly the drug is absorbed into the blood stream.
The population who are eligible to take part in the study are healthy male and female, non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at Simbec.
Participation in the trial will last for about 6/7 weeks (from first screening visit to final end of study visit).
REC name
Wales REC 1
REC reference
16/WA/0303
Date of REC Opinion
30 Nov 2016
REC opinion
Further Information Favourable Opinion