NCT06768632

Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting 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 fasting 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. and Reference Listed Drug (RLD) on an empty stomach to evaluate the human bioequivalence of single dose administration, providing reference for their clinical evaluation and medication.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Group 1: single-dose of test formulation+single-dose of reference formulation	Eltrombopag Tablets is a small molecule non peptide thrombopoietin receptor agonist.
DRUG	Group 2: single-dose of reference formulation+single-dose of test formulation	Eltrombopag Tablets is a small molecule non peptide thrombopoietin receptor agonist.

Timeline

• Start date: 2020-01-02
• Primary completion: 2020-04-27
• Completion: 2023-12-30
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: China