Bioequivalence Studies of Dasatinib 100 Mg

Launched by CENTRO DE ATENCION E INVESTIGACION MEDICA · Jul 12, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to study Dasatinib, a medication used in treating multiple myeloma, by comparing two different formulations of the drug to see if they have the same effects in the body. The trial will involve 46 healthy men aged between 18 and 50 years who have been confirmed to be in good health by a doctor. To participate, individuals must not have any serious health conditions, must not smoke, and should not have taken any medications recently unless they are using a consistent contraceptive method.

Participants in the trial will take a single dose of 100 mg of Dasatinib tablets on four separate occasions, with a week’s break between doses. Throughout the study, they will be monitored closely to ensure their safety and health. It’s important that participants are available for scheduled visits and can provide contact information for themselves and a family member. This trial is not yet recruiting participants, so those interested should stay tuned for updates.

Gender

MALE

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.