Study S000350

A Clinical Study to Evaluate the Relative Bioavailability of HRS-7535 Tablets of Different Formulating Processes and the Effects of Food on New Formulates (Single Center, Random, Open, Cross)

ClinicalTrials.gov record

Registration

Registration: NCT06422039
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 24
Start: 2024-05-23
Primary completion: 2024-08-06
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:HRS-7535(D) Tablets; DRUG:HRS-7535(C) Tablets
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

PK parameters：Cmax [0 hour to 72 hours after the last dosing]
PK parameters：AUC0-t [0 hour to 72 hours after the last dosing]
PK parameters：AUC0-∞ [0 hour to 72 hours after the last dosing]
Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal [0 hour to 72 hours after the last dosing]
Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status [0 hour to 72 hours after the last dosing]

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