OMIX002038

1Summary
Title A Randomized, Double-Blind, Dose-Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics Characteristics of HTD1801 Capsules in Healthy Chinese Subjects after Single Oral Dose
Description This was a randomized, double-blind, placebo-controlled, dose-escalation, and single-dose study, to evaluate the safety, tolerability, and pharmacokinetics of HTD1801 capsules in healthy Chinese adult subjects after single dose under fasting condition (at dose levels of 500 mg, 1000 mg, and 2000 mg), so as to provide data for subsequent exploration of clinically effective dose. This study consisted of 3 dose groups, with a minimum of 8 subjects enrolled per group.
Organism Homo sapiens
Data Type Metabolome Data by Mass Spectrometry (MS)
Data Accessibility Controlled-access
BioProject PRJCA012435
Release Date 2024-12-31
Submitter wang cai e (245454618@qq.com)
Organization The First Affiliated Hospital of Henan University of Science and Technology
Submission Date 2022-10-12
2Files & Download

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File ID File Title Number/Samples File Type File Size File Suffix Download
OMIX002038-02 HTD1801.PCT101_ External Data_2022-01-18_PK_UDCA 480 Metabolome Data by Mass Spectrometry (MS) 4.0 MB xlsx Controlled
OMIX002038-03 HTD1801.PCT101_PK_BBR_Reconciliation Result_17DEC2021 480 Metabolome Data by Mass Spectrometry (MS) 57.7 KB xlsx Controlled
3Relevant Publications
Paper Title Journal Name Publish Time Accession Citing Type

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