Bioequivalence Study of Revolade® Eltrombopag 50 mg

NCT06834451 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: ELTROM-BIO-001-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence Study

Conditions

Healthy; Healthy Donors

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Period 1

ACTIVE COMPARATOR

Revolade® Reference

Drug: Revolade®; Drug: Eltrombopag (EPAG)

Period 2

ACTIVE COMPARATOR

Eltrombopag TEST

Drug: Revolade®; Drug: Eltrombopag (EPAG)

Interventions

Revolade® DRUG

Tableta 50 mg Reference

Also known as: Eltrombopag

Period 1; Period 2

Eltrombopag (EPAG) DRUG

Tableta 50 mg

Period 1; Period 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Atencion e Investigacion Medica: lead

Study Sites (1)

Centro de Atención e Investigación Médica

Chía, Cundinamarca, 111156, Colombia

Location

MeSH Terms

Interventions

eltrombopag

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principla Investigator

Model Details: Bioequivalence study

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 19, 2025
• Study Start: June 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Oct 2024 - Oct 2025
• Access Criteria: Indicate whether a proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed

Locations

CO (1)