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Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional
Comparative Bioavailability of Lenvatinib 10 mg Capsules: A Two-Part, Single-Dose, Open-Label, Randomized, Six-Sequence, Three-Treatment, Three-Period, Crossover Pilot Study in Healthy Subjects Under Fasting and Fed Conditions.
At a glance
Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Bioequivalence Study
Sponsor
Bluepharma Industria Farmaceutica S.A.
Enrolment target
36
Start
03 Mar 2023
Advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.Progressivelocally advanced or metastaticdifferentiated (papillary/follicular/Hurthle cell) thyroid carcinomarefractory to radioactive iodine in adults.Advanced or unresectable hepatocellular carcinoma in adults who have received no prior systemic therapy.
What is this study about?
The following pharmacokinetic parameters will be estimated: maximum observed plasma concentration (Cmax); time of occurrence of Cmax (tmax); area under the plasma concentration versus time curve (AUC) from pre-dose (time zero) to 72 hours (AUC0-72); apparent terminal elimination rate constant (λz); and apparent terminal elimination half-life (t1/2).
Who may be eligible?
Age 18 Years to any · Sex: All
Locations (1)
- —Portugal
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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