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A Trial of SP2086 With Hepatic Insufficiency - Trial NCT06035406

Access comprehensive clinical trial information for NCT06035406 through Pure Global AI's free database. This Phase 1 trial is sponsored by Jiangsu HengRui Medicine Co., Ltd. and is currently Not yet recruiting. The study focuses on Diabetes. Target enrollment is 24 participants.

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NCT06035406
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06035406
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A Trial of SP2086 With Hepatic Insufficiency
Pharmacokinetics and Safety of SP2086 in Subjects With Mild and Moderate Liver Impairment and Normal Liver Function.

Study Focus

Diabetes

Retagliptin Phosphate Tablet

Interventional

drug

Sponsor & Location

Jiangsu HengRui Medicine Co., Ltd.

Timeline & Enrollment

Phase 1

Sep 01, 2023

Dec 01, 2023

24 participants

Primary Outcome

PK parameters๏ผšCmax๏ผ›,PK parameters๏ผšAUC0-t๏ผ›,PK parameters๏ผšAUC0-โˆž๏ผ›

Summary

This study used a single-dose, open design to compare the pharmacokinetics of subjects with
 mild and moderate liver impairment and subjects with normal liver function.

ICD-10 Classifications

Diabetes mellitus
Unspecified diabetes mellitus
Other specified diabetes mellitus
Unspecified diabetes mellitus without complications
Other specified diabetes mellitus without complications

Data Source

ClinicalTrials.gov

NCT06035406

Non-Device Trial