Bioequivalence Studies of Dasatinib 100 Mg
ConditionMyeloma Multiple
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-50
SponsorCentro de Atencion e Investigacion Medica
About this trial
A bioequivalence study of Dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg of Dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between each dose
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men of legal age between 18 to 50 years.
Have been clinically diagnosed as healthy by the trial doctor.
Subjects with clinical laboratory results within normal ranges and/or suitable by medical selection.
Non-smoking subjects for the last 3 months.
Disqualifiers
Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease.
Subjects diagnosed with positive COVID 19
Subject diagnosed with hematological disorders, such as anemia and/or polycythemia.
Subjects with a history of gastric surgeries.
Trial design
Design model
Sequential
Treatments tested in this trial
Dasatinib 100 MG
Drugsingle dose of 100 mg Dasatinib tablets
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Liteda®Active comparator 1 intervention
Group B: Sprycel®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Time frame
2 days2
AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose
Bioequivalence based on AUC0-24
Time frame
2 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: