Study S002756

A Randomized, Open Phase I Trial to Evaluate the Bioavailability, Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet and Evaluate the Effect of Meal Time on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet in Chinese Healthy Adult Subjects

ClinicalTrials.gov record

Registration

Registration: NCT06554054
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: UNKNOWN
Enrollment: 92
Start: 2024-04-01
Primary completion: 2024-12-09
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:GZR18
Results posted: FALSE

Registered primary outcomes

AE and SAE [22 days and 35 days]
Relative bioavailability of GZR18 tablet [22 days and 35 days]
ADA and NAb [22 days and 35 days]

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