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Trial Title:
Bioequivalence Studies of Dasatinib 100 mg
NCT ID:
NCT05944783
Condition:
Myeloma Multiple
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dasatinib
Conditions: Keywords:
Dasatinib , fed condition, bioequivalence
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Dasatinib bioequivalence study in fed condition
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
randomized
Intervention:
Intervention type:
Drug
Intervention name:
Dasatinib 100 MG
Description:
single dose of 100 mg Dasatinib tablets
Arm group label:
Liteda®
Arm group label:
Sprycel®
Other name:
sprycel
Summary:
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
Detailed description:
A bioequivalence study of Dasatinib in 46 healthy subjects, in fed condition, complete
replicated design, comparative of 2 sequences, 2 formulations, single dose of 100 mg of
Dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between
each dose
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- Have signed the informed consent.
- Body mass index between 18-30 kg/m2
- Subject with complete contact information (cell phone and/or contact landline,
address, email).
- Subject who has a family member or guardian with a contact telephone number.
- Subject to the availability of time to comply with scheduled visits and activities.
Exclusion Criteria:
- 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.
- Permanent or temporary use during the last 15 days of any type of medication, both
on their own initiative and by medical prescription. Except female patients who are
planning regularly with the same contraceptive method in the last 6 months prior to
the start of this trial.
- Smoker in the last 3 months, regardless of the number of cigarettes.
- Consumption of xanthines from coffee, tea or chocolate during the previous 48 hours
- Drinker of alcohol in more than 16 grams every week equivalent to 1 beer or 2
glasses of wine during the last 15 days.
- Consumption of drugs of abuse or psychoactive substances reported as a positive
test.
- Known hypersensitivity to the active substance or to the excipients of the test
product.
- Medical history of angioedema or anaphylaxis.
- Subject diagnosed with human immunodeficiency virus infection, hepatitis B or
positive hepatitis C.
- Have participated in clinical studies in the 4 months prior to the start of this
trial.
- Have donated blood in the 30 days prior to the start of the trial.
Gender:
Male
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
CAIMED
Address:
City:
Chia
Country:
Colombia
Start date:
November 1, 2023
Completion date:
January 30, 2024
Lead sponsor:
Agency:
Centro de Atencion e Investigacion Medica
Agency class:
Other
Source:
Centro de Atencion e Investigacion Medica
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05944783
https://www.jscimedcentral.com/Bioavailability/bioavailability-2-1007.pdf
