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The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult Subjects

NCT05787041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-12-01

No results posted yet for this study

Summary

The study was a single-center, randomized, open-access, two-crossover, single-dose study design with 16 subjects to evaluate the pharmacokinetics of a high-fat diet on a single dose of oral AD16 tablets in healthy Chinese adults and the safety of a single dose of oral AD16 tablets in healthy Chinese adults.

Compared with fasting administration, a high-fat diet reduced the rate of AD16 tablet absorption in healthy adult subjects and had no effect on overall exposure to AD16.

The elimination and distribution characteristics of AD16 in vivo were similar under the conditions of feeding and fasting administration.

A single dose of AD16 tablets after fasting and high fat diet showed good safety.

Conditions

  • Alzheimer Disease

Interventions

OTHER

high-fat diet group（AD16 20mg）

AD16 was administered with 240 mL water 30 minutes after the subjects ate a high-fat, high-calorie food.

OTHER

fasted group（AD16 20mg）

Subjects took AD16 on an empty stomach and fasted within 4 hours after taking the drug.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • South China Center For Innovative Pharmaceuticals

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2019-12-14
Completion
2019-12-14

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 NCT05787041 on ClinicalTrials.gov