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Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects - Trial NCT06422039

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.

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NCT06422039
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06422039
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DJ Fang

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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)

Study Focus

Type 2 Diabetes Mellitus

HRS-7535๏ผˆD๏ผ‰Tablets

Interventional

drug

Sponsor & Location

Shandong Suncadia Medicine Co., Ltd.

Hefei, China

Timeline & Enrollment

Phase 1

May 15, 2024

Jun 15, 2024

18 participants

Primary Outcome

PK parameters๏ผšCmax,PK parameters๏ผšAUC0-t,PK parameters๏ผšAUC0-โˆž,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 mellitus
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06422039

Non-Device Trial