Bioequivalence Study of Revolade® Eltrombopag 50 mg (Eltrombopag)

Bioequivalence Study of Revolade® Eltrombopag 50 mg Tablets - Novartis Vs Myelone ® Eltrombopag 50 mg Tablets - Colompack / Immediate Release Tablets in Healthy Subjects Under Fasting Condition

Bioequivalence Study

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Healthy Donors
• Intervention / Treatment: Drug: Revolade®; Drug: Eltrombopag (EPAG)

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Chía, Cundinamarca, Colombia, 111156
      • Centro de Atención e Investigación Médica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Period 1; Revolade® Reference	Drug: Revolade®; Tableta 50 mg Reference; Other Names: Eltrombopag; Drug: Eltrombopag (EPAG); Tableta 50 mg
Active Comparator: Period 2; Eltrombopag TEST	Drug: Revolade®; Tableta 50 mg Reference; Other Names: Eltrombopag; Drug: Eltrombopag (EPAG); Tableta 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Outcome Measures	Peak Plasma Concentration (Cmax)	0- 6 hours
Pharmacokinetic Outcome Measures	Area under the plasma concentration versus time curve (AUC)	0 - 6 hours

Collaborators and Investigators

• Sponsor: Centro de Atencion e Investigacion Medica

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Bioequivalence
• Other Study ID Numbers: ELTROM-BIO-001-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: Oct 2024 - Oct 2025
• IPD Sharing Access Criteria: Indicate whether a proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No