NCT05025072

A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Theravia · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Hydroxycarbamide dispersible tablets	Hydroxycarbamide dispersible tablets (20 x 50 mg)
DRUG	Hydroxycarbamide film-coated tablet	Hydroxycarbamide film-coated tablet (1000 mg)

Timeline

• Start date: 2021-08-22
• Primary completion: 2021-09-29
• Completion: 2021-09-29
• First posted: 2021-08-27
• Last updated: 2021-10-07

Locations

1 site across 1 country: United Kingdom