Bioequivalence Study of Revolade® Eltrombopag 50 mg

Centro de Atencion e Investigacion Medica

Status and phase: Active, not recruiting; Phase 4

Conditions: Healthy; Healthy Donors

Treatments: Drug: Eltrombopag (EPAG); Drug: Revolade®

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06834451

ELTROM-BIO-001-2023

Details and patient eligibility

About

Bioequivalence Study

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Period 1

Active Comparator group

Description:

Revolade® Reference

Treatment:

Drug: Revolade®

Drug: Eltrombopag (EPAG)

Period 2

Active Comparator group

Description:

Eltrombopag TEST

Treatment:

Drug: Revolade®

Drug: Eltrombopag (EPAG)