Bioequivalence Studies of Dasatinib 100 mg

Myeloma Multiple Clinical Trial

— BE-Dasatinib  

Official title:

Bioequivalence Studies of Dasatinib 100 mg Tablets in Healthy Colombian Subjects in Postprandial Condition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05944783
• Other study ID #: DASAT-BIO-001-2022
• Secondary ID: DASAT-BIO-001-20
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: July 2023
• Source: Centro de Atencion e Investigacion Medica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: January 30, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

Intervention

Drug:
• Dasatinib 100 MG
single dose of 100 mg Dasatinib tablets

Locations

Country	Name	City	State
Colombia	CAIMED	Chia	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Atencion e Investigacion Medica

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax - Maximum Observed Concentration	Bioequivalence based on Cmax	2 days
Primary	AUC0-24 - Area Under the Concentration-time Curve From Time Zero to 24 Hours Post-dose	Bioequivalence based on AUC0-24	2 days

External 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