Myeloma MultiplePhase 4BE-DasatinibNCT05944783
Bioequivalence Studies of Dasatinib 100 Mg
A Phase 4 study testing Dasatinib 100 MG in people with Myeloma Multiple, run by Centro de Atencion e Investigacion Medica at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Myeloma Multiple
- What is being tested?
- Dasatinib 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteColombia
- Study dates
- 1 Sep 2025to 30 Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bioequivalence Studies of Dasatinib 100 Mg Tablets in Healthy Colombian Subjects in Postprandial Condition
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
Read the 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
- Conditions
- Myeloma Multiple
- Being tested
- Dasatinib 100 MG
- Keywords
- Dasatinib , fed condition, bioequivalence
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib 100 MGDrug
Also called sprycel
single dose of 100 mg Dasatinib tablets
| Study group | Role | What they receive |
|---|---|---|
| Liteda® | Active comparator | Dasatinib 100 mg tablets Lab. Tecnofarma Colombia S.A.S. Liteda® Receives: Drug: Dasatinib 100 MG |
| Sprycel® | Active comparator | Dasatinib 100 mg tablets Lab. Bristol-Myer Squibb Sprycel® Receives: Drug: Dasatinib 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Measured: 2 days
AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose
Bioequivalence based on AUC0-24
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Sep 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dasatinib bioequivalence study in fed condition
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atencion e Investigacion Medica
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Humberto Reynales MD MSc PhD, Centro de Atencion e Investigacion Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944783
- Sponsor's protocol ID
- DASAT-BIO-001-2022
- Other IDs
- DASAT-BIO-001-2022
- Acronym
- BE-Dasatinib
- Status last verified
- Feb 2025
- First submitted
- 11 Aug 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Studies of Dasatinib 100 Mg Tablets in Healthy Colombian Subjects in Postprandial Condition
- ClinicalTrials.gov ID
- NCT05944783
- Acronym / sponsor ID
- BE-Dasatinib / DASAT-BIO-001-2022
- Conditions
- Myeloma Multiple
- Keywords
- Dasatinib , fed condition, bioequivalence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centro de Atencion e Investigacion MedicaResearch network
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dasatinib bioequivalence study in fed condition
| Arm | Type | Receives |
|---|---|---|
| Liteda® | Active comparator | Drug: Dasatinib 100 MGDasatinib 100 mg tablets Lab. Tecnofarma Colombia S.A.S. Liteda® |
| Sprycel® | Active comparator | Drug: Dasatinib 100 MGDasatinib 100 mg tablets Lab. Bristol-Myer Squibb Sprycel® |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib 100 MGAlso: sprycelsingle dose of 100 mg Dasatinib tablets | Drug | Liteda®, Sprycel® |
Primary outcome
Cmax - Maximum Observed Concentration
Time frame: 2 days
Bioequivalence based on Cmax
AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose
Time frame: 2 days
Bioequivalence based on AUC0-24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- An open-label, balanced, randomized, two treatments, two sequences, four periods, fully replicate, crossover study to evaluate the bioequivalence of Dasatinib 100 mg film-coated tablets of Abbott Laboratories versus Sprycel® (Dasatinib) 100 mg filmcoatedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dasatinib 100 MG in people with Myeloma Multiple, run by Centro de Atencion e Investigacion Medica at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax - Maximum Observed Concentration (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.