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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05025072
Study type Interventional
Source ADDMEDICA SASA
Contact Corinne Duguet, MD
Phone +33 1 49 70 95 85
Email [email protected]
Status Recruiting
Phase Phase 1
Start date August 22, 2021
Completion date September 17, 2021

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