The Pharmacokinetic and Bioavailability of GenSci094 Before and After a Change in Manufacturing Site
Status:
Recruiting
Trial end date:
2024-03-31
Target enrollment:
Participant gender:
Summary
The bioavailability study is intended to evaluate the pharmacokinetic (PK) characteristics
and the bioavailability of the two formulations in humans before and after the change of
production site, in order to assess the possible impact of the site change on the
pharmacokinetic characteristics of the drug and to clarify whether the two formulations are
comparable before and after the change.
Phase:
Phase 1
Details
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborator:
Affiliated Hospital of North Sichuan Medical College