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

Alzheimer Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05787041
Study type Interventional
Source South China Center For Innovative Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date June 14, 2019
Completion date December 14, 2019
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