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Bioequivalence Studies of Dasatinib 100 Mg

Phase 4
Not yet recruiting
Conditions
Myeloma Multiple
Interventions
Registration Number
NCT05944783
Lead Sponsor
Centro de Atencion e Investigacion Medica
Brief 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

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Male
Target Recruitment
46
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Liteda®Dasatinib 100 MGDasatinib 100 mg tablets Lab. Tecnofarma Colombia S.A.S. Liteda®
Sprycel®Dasatinib 100 MGDasatinib 100 mg tablets Lab. Bristol-Myer Squibb Sprycel®
Primary Outcome Measures
NameTimeMethod
Cmax - Maximum Observed Concentration2 days

Bioequivalence based on Cmax

AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose2 days

Bioequivalence based on AUC0-24

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CAIMED

🇨🇴

Chia, Cundinamarca, Colombia

CAIMED
🇨🇴Chia, Cundinamarca, Colombia

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