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Bioequivalence Studies of Dasatinib 100 mg (BE-Dasatinib)

Primary Purpose

Myeloma Multiple

Status
Not yet recruiting
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Dasatinib 100 MG
Sponsored by
Centro de Atencion e Investigacion Medica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloma Multiple focused on measuring Dasatinib , fed condition, bioequivalence

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • CAIMED

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Liteda®

Sprycel®

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose
Bioequivalence based on AUC0-24

Secondary Outcome Measures

Full Information

First Posted
August 11, 2022
Last Updated
July 12, 2023
Sponsor
Centro de Atencion e Investigacion Medica
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1. Study Identification

Unique Protocol Identification Number
NCT05944783
Brief Title
Bioequivalence Studies of Dasatinib 100 mg
Acronym
BE-Dasatinib
Official Title
Bioequivalence Studies of Dasatinib 100 mg Tablets in Healthy Colombian Subjects in Postprandial Condition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Atencion e Investigacion Medica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma Multiple
Keywords
Dasatinib , fed condition, bioequivalence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
Dasatinib bioequivalence study in fed condition
Masking
InvestigatorOutcomes Assessor
Masking Description
randomized
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liteda®
Arm Type
Active Comparator
Arm Description
Dasatinib 100 mg tablets Lab. Tecnofarma Colombia S.A.S. Liteda®
Arm Title
Sprycel®
Arm Type
Active Comparator
Arm Description
Dasatinib 100 mg tablets Lab. Bristol-Myer Squibb Sprycel®
Intervention Type
Drug
Intervention Name(s)
Dasatinib 100 MG
Other Intervention Name(s)
sprycel
Intervention Description
single dose of 100 mg Dasatinib tablets
Primary Outcome Measure Information:
Title
Cmax - Maximum Observed Concentration
Description
Bioequivalence based on Cmax
Time Frame
2 days
Title
AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose
Description
Bioequivalence based on AUC0-24
Time Frame
2 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
CAIMED
City
Chia
State/Province
Cundinamarca
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.jscimedcentral.com/Bioavailability/bioavailability-2-1007.pdf
Description
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

Learn more about this trial

Bioequivalence Studies of Dasatinib 100 mg

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