NCT04688008

Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations

An Open-label, Randomized, Single-dose, Two -Period, Crossover Study to Investigate the Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations in Healthy Chinese Adult Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the relative bioavailability of early phase and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under fasting conditions. The secondary objective of the study is to evaluate the safety of hetrombopag olamine in healthy Chinese adult subjects.

Conditions

• Bioavailability Study

Interventions

Type	Name	Description
DRUG	Hetrombopag	Drug: Early phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions Drug: Late phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions

Timeline

• Start date: 2020-09-18
• Primary completion: 2020-10-12
• Completion: 2020-10-30
• First posted: 2020-12-29
• Last updated: 2021-02-26

Locations

1 site across 1 country: China