Comparative Bioavailability of Nilotinib 200 mg Hard Capsules: A Single-Dose, Open-Label, Randomized, Four-Sequence, Four-Treatment, Four-Period Crossover Pilot Study in Healthy Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501325-20-00

Acronym

BLCL-NIL-PIL03

Enrollment

Registered

2022-10-03

Start date

2022-10-06

Completion date

2022-11-11

Last updated

2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Philadelphia-chromosome positive leukemia cells from chronic myelogenous leukemia (CML)

Brief summary

The following pharmacokinetic endpoints will be estimated: Cmax; tmax; AUC) from pre-dose (time zero) to the last sampling time with quantifiable concentrations (AUC0-t); AUC from time zero to infinity (AUC0-∞); residual area or percentage of extrapolated part of AUC0-∞ (%AUCextrap); λz; and t1/2.

Detailed description

Safety will be evaluated through the assessment of adverse events (AEs), ECG, vital signs, and clinical laboratory tests.

Interventions

DRUGNilotinib

DRUGTasigna 200 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The following pharmacokinetic endpoints will be estimated: Cmax; tmax; AUC) from pre-dose (time zero) to the last sampling time with quantifiable concentrations (AUC0-t); AUC from time zero to infinity (AUC0-∞); residual area or percentage of extrapolated part of AUC0-∞ (%AUCextrap); λz; and t1/2.	—

Secondary

Measure	Time frame
Safety will be evaluated through the assessment of adverse events (AEs), ECG, vital signs, and clinical laboratory tests.	—

Countries

Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026