Bioequivalence Study of Revolade® Eltrombopag 50 mg

NCT ID: NCT06834451

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-10-30

Brief Summary

Bioequivalence Study

Detailed Description

A bioequivalence study of Eltrombopag will be developed in 30 healthy subjects, under fasting condition, following the design:

Open-label, crossover, randomized, single-dose design of 50 mg Eltrombopag tablets/immediate release tablets, with two treatments, two periods, two sequences in healthy volunteers in fasting condition, with a washout time of 15 days between each dose

Conditions

Healthy; Healthy Donors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Period 1

Revolade® Reference

Group Type: ACTIVE_COMPARATOR

Revolade®

Intervention Type: DRUG

Tableta 50 mg Reference

Eltrombopag (EPAG)

Intervention Type: DRUG

Tableta 50 mg

Period 2

Eltrombopag TEST

Group Type: ACTIVE_COMPARATOR

Revolade®

Intervention Type: DRUG

Tableta 50 mg Reference

Eltrombopag (EPAG)

Intervention Type: DRUG

Tableta 50 mg

Interventions

Revolade®

Tableta 50 mg Reference

Intervention Type: DRUG

Eltrombopag (EPAG)

Tableta 50 mg

Intervention Type: DRUG

Other Intervention Names

Eltrombopag

Eligibility Criteria

Inclusion Criteria

• Women and men between 18 and 50 years of age. Have been clinically diagnosed as healthy by the trial physician. Subjects with clinical laboratory results requested in the protocol (Table 2) within normal ranges and/or fit by medical screening. Current for 3 months.

Subjects non-smokers for the last 3 months. Having signed the informed consent. Subjects sexually active or of reproductive age must use an effective contraceptive method during and for at least 7 days after the end of the study.

Body mass index between 18-30 kg/m2 at the time of inclusion in the study. Subject with complete contact information (cell phone and/or landline contact, address, email).

Subject who has a family member or guardian with a contact telephone number. Subject with the availability of time to comply with the scheduled visits and activities.

Exclusion Criteria

• Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease.

Woman in a state of pregnancy or breastfeeding. Subject diagnosed with hematological disorders, such as anemias and/or polycythemia.

Subjects with a history of gastric surgeries. Permanent or temporary use during the last 15 days of any type of medication either on their own initiative or 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 the present trial.

Consumption of xanthines from coffee, tea or chocolate during the 48 hours prior to hospitalization.

Drinking alcohol in excess of 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days prior to hospitalization.

Consumption of drugs of abuse or psychoactive substances reported as positive test at the time of hospitalization.

Known hypersensitivity to the active ingredient or excipients of the test product.

Medical history of angioedema or anaphylaxis. Subject diagnosed with human immunodeficiency virus infection, hepatitis B or hepatitis C positive.

Having participated in clinical studies in the 4 months prior to the time of signing the informed consent.

Having donated blood in the 30 days prior to the time of signing the informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Atencion e Investigacion Medica

NETWORK

Sponsor Role: lead

Responsible Party

Humberto Reynales MD MSc PhD

Principla Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Atención e Investigación Médica

Chía, Cundinamarca, Colombia

Countries

Colombia

Other Identifiers

ELTROM-BIO-001-2023

Identifier Type: -

Identifier Source: org_study_id