Bioequivalence Studies of Dasatinib 100 Mg

NCT ID: NCT05944783

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-04-30

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

Conditions

Myeloma Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Liteda®

Dasatinib 100 mg tablets Lab. Tecnofarma Colombia S.A.S. Liteda®

Group Type: ACTIVE_COMPARATOR

Dasatinib 100 MG

Intervention Type: DRUG

single dose of 100 mg Dasatinib tablets

Sprycel®

Dasatinib 100 mg tablets Lab. Bristol-Myer Squibb Sprycel®

Group Type: ACTIVE_COMPARATOR

Dasatinib 100 MG

Intervention Type: DRUG

single dose of 100 mg Dasatinib tablets

Interventions

Dasatinib 100 MG

single dose of 100 mg Dasatinib tablets

Intervention Type: DRUG

Other Intervention Names

sprycel

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Atencion e Investigacion Medica

NETWORK

Sponsor Role: lead

Responsible Party

Humberto Reynales MD MSc PhD

Dr MD MSc PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CAIMED

Chía, Cundinamarca, Colombia

Countries

Colombia

Related Links

https://www.jscimedcentral.com/Bioavailability/bioavailability-2-1007.pdf

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 filmcoated

Other Identifiers

DASAT-BIO-001-2022

Identifier Type: OTHER

Identifier Source: secondary_id

DASAT-BIO-001-2022

Identifier Type: -

Identifier Source: org_study_id