A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers
Status:
Completed
Trial end date:
2021-09-29
Target enrollment:
Participant gender:
Summary
This study is a Phase I, open-label, single-centre, randomised, two-period, single-dose
crossover study to compare and assess the bioequivalence, safety, tolerability and
pharmacokinetics of hydroxycarbamide dispersible tablets (20 x 50 mg) (test IMP) and Siklos®
film-coated tablet (1000 mg) (reference IMP) following single-dose administration. Thirty
(30) healthy male and female participants, between 18 and 50 years of age are planned to
participate in the study.
Study participants will be randomised to one of the 2 possible combination sequences. After
each treatment administration, blood samples will be collected at specific time points to
assess the Pharmacokinetics (PK) parameters.