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Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State

NCT06768619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-16

No results posted yet for this study

Summary

The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fed conditions. According to the randomized crossover self-control method, healthy volunteer subjects were orally administered with Eltrombopag Olamine Tablets produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Evaluate the human bioequivalence of single dose Reference Listed Drug (RLD) after meals, providing reference for clinical evaluation and medication use.

Conditions

Interventions

DRUG

Group 1: single-dose of test formulation+single-dose of reference formulation

Eltrombopag olamine is a small molecule non peptide thrombopoietin receptor agonist.

DRUG

Group 2: single-dose of reference formulation+single-dose of test formulation

Eltrombopag olamine is a small molecule non peptide thrombopoietin receptor agonist.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2023-04-27
Completion
2023-04-27

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06768619 on ClinicalTrials.gov