NCT06768619

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

A Multicenter, Randomized, Open-label, Two-formulation, Two-sequence, Two-period Crossover Study to Evaluate the Bioequivalence of Eltrombopag Olamine Tablets (25 mg) in Healthy Chinese Subjects in the Fed State

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Thrombocytopenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-04-27
• Completion: 2023-04-27
• First posted: 2025-01-10
• Last updated: 2025-12-16

Locations

1 site across 1 country: China