NCT05944783Not yet recruitingPhase 4
Bioequivalence Studies of Dasatinib 100 Mg
Bioequivalence Studies of Dasatinib 100 Mg Tablets in Healthy Colombian Subjects in Postprandial Condition
Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 11 Aug 2022
- Start date
- 1 Sept 2025
- Primary completion date
- 20 Dec 2025
- Lead sponsor
- Centro de Atencion e Investigacion Medica
- Diseases
- Multiple myeloma
- NCT number
- NCT05944783
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 46
- From 1 Sept 2025 to the primary completion date, 20 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Consumption of xanthines from coffee, tea or chocolate during the previous 48 hours
- Consumption of drugs of abuse or psychoactive substances reported as a positive test.
- 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.
Other illness
- 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.
- 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.
Other
- Smoker in the last 3 months, regardless of the number of cigarettes.
- Drinker of alcohol in more than 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CAIMED Coordinator of this site? Confirm its status | Chía | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.