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| Name | Class |
|---|---|
| Xiangya Hospital of Central South University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-fat diet group | Experimental | A single dose of AD16 tablets was taken orally after a high fat diet |
|
| Fasting group | Experimental | A single dose of AD16 tablets was taken orally under fasting conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-fat diet group(AD16 20mg) | Other | AD16 was administered with 240 mL water 30 minutes after the subjects ate a high-fat, high-calorie food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of AD16 | Maximum (peak) plasma drug concentration | Up to Day 10 |
| AUC 0-t of AD16 | Area under the plasma concentration-time curve(AUC) from time zero to time t | Up to Day 10 |
| AUC 0-∞ of AD16 | Area under the plasma concentration-time curve(AUC) from time zero to infinity | Up to Day 10 |
| t1/2 of AD16 | Elimination half-life (to be used in a one-compartment or noncompartmental model) | Up to Day 10 |
| Tmax of AD16 | Time to reach the maximum (peak) plasma concentration following drug administration | Up to Day 10 |
| CL/F of AD16 | CL/F is defined as the ratio of total clearance(CL) to bioavailability(F). | Up to Day 10 |
| Vd/F of AD16 | Apparent volume of distribution after non-intravenous administration | Up to Day 10 |
| MRT of AD16 | Mean residence time(MRT) | Up to Day 10 |
| λz of AD16 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The number of adverse events | day-7 to day 10 |
| Serious adverse events | The number of serious adverse events | day-7 to day 10 |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Central South University Xiang Ya Hospital | Changsha | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37996817 | Derived | Peng D, Xu S, Zou T, Wang Y, Ouyang W, Zhang Y, Dong C, Li D, Guo J, Shen Q, Hu X, Zhou W, Li X, Qin Q. Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study. BMC Med. 2023 Nov 23;21(1):459. doi: 10.1186/s12916-023-03126-9. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| fasted group(AD16 20mg) | Other | Subjects took AD16 on an empty stomach and fasted within 4 hours after taking the drug. |
|
Terminal disposition rate constant/terminal rate constant |
| Up to Day 10 |
| Number of participants with abnormal laboratory test results | Laboratory tests include blood routine, blood biochemistry, coagulation function and urine routine | day-7 to day-1 and day10 |
| Number of participants with abnormal vital signs | vital signs include Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication. | day-7 to day3 and day7 to day10 |
| Number of participants with abnormal 12- Lead ECG readings | abnormal 12- Lead ECG | day-7 to day-1 and days3 、10 |
| Number of participants with abnormal physical examination findings | The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication. | day-7 to day-1 and day10 |
| Concomitant medication | Any concomitant medication | Up to Day 10 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |