NCT05787041

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: South China Center For Innovative Pharmaceuticals · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-06-14
• Primary completion: 2019-12-14
• Completion: 2019-12-14
• First posted: 2023-03-28
• Last updated: 2023-12-01

Locations

1 site across 1 country: China