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NCT06422039Not yet recruiting

Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects

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)
Shandong Suncadia Medicine Co., Ltd.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Type 2 Diabetes Mellitus
Drug/Device/Intervention
HRS-7535（D）Tablets
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shandong Suncadia Medicine Co., Ltd.
Location
Hefei, China
Timeline & enrollment
Phase
Phase 1
Start date
May 15, 2024
End date
Jun 15, 2024
Enrollment
18 participants
Primary outcome

PK parameters：Cmax,PK parameters：AUC0-t,PK parameters：AUC0-∞,Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal,Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status

Summary

This study was designed as a a single-center, randomized, open, interleaved (3-cycle,
 3-sequence) trial. It is planned to enroll 18 healthy subjects.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06422039
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06422039 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shandong Suncadia Medicine Co., Ltd. and is currently Not yet recruiting. The study focuses on Type 2 Diabetes Mellitus. Target enrollment is 18 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.