Bioequivalence Studies of Dasatinib 100 Mg (BE-Dasatinib)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Myeloma Multiple
• Intervention / Treatment: Drug: Dasatinib 100 MG

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 Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Chia, Cundinamarca, Colombia
      • CAIMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liteda®; Dasatinib 100 mg tablets Lab. Tecnofarma Colombia S.A.S. Liteda®	Drug: Dasatinib 100 MG; single dose of 100 mg Dasatinib tablets; Other Names: sprycel
Active Comparator: Sprycel®; Dasatinib 100 mg tablets Lab. Bristol-Myer Squibb Sprycel®	Drug: Dasatinib 100 MG; single dose of 100 mg Dasatinib tablets; Other Names: sprycel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centro de Atencion e Investigacion Medica

Publications and helpful links

Helpful 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

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Dasatinib , fed condition, bioequivalence
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Dasatinib
• Other Study ID Numbers: DASAT-BIO-001-2022 (Other Identifier: CAIMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No