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

NCT05025072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-10-07

No results posted yet for this study

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

DRUG

Hydroxycarbamide dispersible tablets

Hydroxycarbamide dispersible tablets (20 x 50 mg)

DRUG

Hydroxycarbamide film-coated tablet

Hydroxycarbamide film-coated tablet (1000 mg)

Sponsors & Collaborators

  • Simbec-Orion Group

    collaborator INDUSTRY

  • Oncodesign SA

    collaborator INDUSTRY

  • PhinC Development

    collaborator INDUSTRY

  • Theravia

    lead INDUSTRY

Principal Investigators

  • Annelize Koch, MD · Simbec-Orion Group

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-22
Primary Completion
2021-09-29
Completion
2021-09-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05025072 on ClinicalTrials.gov