NCT05486598

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

A Phase IB Clinical Trial to Evaluate the Effect of High-fat Diet on Pharmacokinetics of AL8326 Tablets in Chinese Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Advenchen Laboratories Nanjing Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a Phase IB Clinical Trial to Evaluate the Effect of High-fat Diet on Pharmacokinetics of AL8326 Tablets in Chinese Healthy Adult Subjects. Sixteen healthy subjects were randomly divided into two sequence groups, a and B, and eight subjects in each sequence group were dosed according to either the fasting → postprandial or the postprandial → fasting sequence. The washout period was 14 days.

Conditions

• Diet, High-Fat
• Pharmacokinetics

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-21
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-08-03
• Last updated: 2022-08-03

Locations

1 site across 1 country: China