NCT04395053

A Bioavailability Study of SHR1459 on Healthy Chinese Volunteers

Pharmacokinetic Evaluation Study of Healthy Chinese Volunteers After Oral Administration of SHR1459 Tablets in Old and New Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations. The secondary objective of the study is to evaluate the safety after single dose of SHR1459 orally in healthy Chinese subjects.

Detailed description

The PK parameters (AUC0-t, AUC0-inf, Cmax, Tmax, T1/2z, CL/F and Vz/F etc.) will be calculated to evaluate the pharmacokinetics of healthy Chinese volunteers after oral administration of SHR1459 tablets in new and old formulations. During the study, the safety will be assessed by vital signs, physical examination, laboratory examination (hematology, blood biochemistry, urinalysis, coagulation examination), 12-lead electrocardiogram. The incidence and severity degree of adverse events and severe adverse events will be evaluated based on CTCAE 5.0.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	SHR1459	TR group: The first period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h. RT group: The first period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h.

Timeline

• Start date: 2020-06-28
• Primary completion: 2020-07-11
• Completion: 2020-08-01
• First posted: 2020-05-20
• Last updated: 2022-11-07

Locations

1 site across 1 country: China