Clincosm LogoSign in Get a demo

BE-Dasatinib: Bioequivalence Studies of Dasatinib 100 mg

Sponsor
Centro de Atencion e Investigacion Medica (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05944783
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
3
Anticipated Duration (Months)
15.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dasatinib 100 MG
 Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Dasatinib bioequivalence study in fed conditionDasatinib bioequivalence study in fed condition
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
randomized
Primary Purpose:
Treatment
Official Title:
Bioequivalence Studies of Dasatinib 100 mg Tablets in Healthy Colombian Subjects in Postprandial Condition
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 20, 2023
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax - Maximum Observed Concentration [2 days]

      Bioequivalence based on Cmax

    2. AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose [2 days]

      Bioequivalence based on AUC0-24

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CAIMED Chia Cundinamarca Colombia

    Sponsors and Collaborators

    • Centro de Atencion e Investigacion Medica

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Humberto Reynales MD MSc PhD, Dr MD MSc PhD, Centro de Atencion e Investigacion Medica
    ClinicalTrials.gov Identifier:
    NCT05944783
    Other Study ID Numbers:
    • DASAT-BIO-001-2022
    • DASAT-BIO-001-2022
    First Posted:
    Jul 13, 2023
    Last Update Posted:
    Jul 13, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Humberto Reynales MD MSc PhD, Dr MD MSc PhD, Centro de Atencion e Investigacion Medica
    Dasatinib , fed condition, bioequivalence
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Dasatinib

    Study Results

    No Results Posted as of Jul 13, 2023