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A Study of Diet Influence of AL8326 in Chinese Healthy Adult Subjects

NCT05486598 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-08-03

No results posted yet for this study

Summary

Main study objective: the pharmacokinetic effects of high-fat diet on AL8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.

Secondary study objectives: safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects

Conditions

  • Diet, High-Fat
  • Pharmacokinetics

Interventions

DRUG

AL8326 tablets

Sequence A group: on the 1st day, take a single dose of AL8326 tablets on an empty stomach. On the 15th day, take a single dose of AL8326 tablets after meals. Sequence B group: on the 1st day after meal, take a single dose of AL8326 tablets; on the 15th day, take a single dose of AL8326 tablets on an empty stomach.

Sponsors & Collaborators

  • Advenchen Laboratories Nanjing Ltd.

    lead INDUSTRY

Principal Investigators

  • Yu Cao · The Affiliated Hospital of Qingdao University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05486598 on ClinicalTrials.gov