Study S001534

A Relative Bioavailability Study of Single-dose, Randomized, Open-label, Single-period, Parallel Design of HRS9531 Injection Using Different Manufacturing Processes in Healthy Subjects

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT05893576
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 50
Start: 2023-05-15
Primary completion: 2023-09-04
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:HRS9531
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

Area Under the Concentration versus time curve (AUC) of HRS953 [Start of treatment up to Day 43]
Maximum Concentration (Cmax) of HRS9531 [Start of Treatment up to Day 43]
Calculate the ratio of bioavailability between the new formulation and original formulation of HRS9531 according to the equation F (relative bioavailability) =AUCT·DR/AUCR·DT×100% [Start of Treatment up to Day 43]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.