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KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Completed PHASE1 INTERVENTIONAL NCT05025072

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

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

Primary Outcomes

Measure: Cmax
TimeFrame: 24 hours
Description: The observed maximum concentration (Cmax) in plasma
Measure: AUC0-t
TimeFrame: 24 hours
Description: The area under the plasma concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (t)
Measure: AUC0-infinity
TimeFrame: 24 hours
Description: The AUC from time 0 to infinity

Trial Information

NCT ID

NCT05025072

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Theravia

Last Updated

December 15, 2025