Bioequivalence Studies of Dasatinib 100 Mg

NCT05944783 | Not Yet Recruiting Phase 4

• 1 other identifier: DASAT-BIO-001-2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Myeloma Multiple

Keywords

Dasatinib , fed condition, bioequivalence

Outcome Measures

Primary Outcomes (2)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  2 days

• AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose

  Bioequivalence based on AUC0-24

  2 days

Study Arms (2)

Liteda®

ACTIVE COMPARATOR

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

Drug: Dasatinib 100 MG

Sprycel®

ACTIVE COMPARATOR

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

Drug: Dasatinib 100 MG

Interventions

Dasatinib 100 MG DRUG

single dose of 100 mg Dasatinib tablets

Also known as: sprycel

Liteda®; Sprycel®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Atencion e Investigacion Medica: lead

Study Sites (1)

CAIMED

Chía, Cundinamarca, Colombia

Location

Related Links

• 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

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomized
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr MD MSc PhD

Model Details: Dasatinib bioequivalence study in fed condition

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: July 13, 2023
• Study Start: September 1, 2025
• Primary Completion: December 20, 2025
• Study Completion: April 30, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)