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COMPLETED
NCT05025072
PHASE1

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

Sponsor: Theravia

View on ClinicalTrials.gov

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 hydroxycarbamide 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.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2021-07-30

Completion Date

2021-09-29

Last Updated

2026-09-29

Healthy Volunteers

Yes

Interventions

DRUG

Hydroxycarbamide dispersible tablets

Hydroxycarbamide dispersible tablets (20 x 50 mg)

DRUG

Hydroxycarbamide film-coated tablet

Hydroxycarbamide film-coated tablet (1000 mg)

Locations (1)

Simbec-Orion Clinical Pharmacology

Merthyr Tydfil, United Kingdom