CompletedNCT05787041Updated Dec 1, 2023

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

A Phase 1 interventional study of high-fat diet group（AD16 20mg） and fasted group（AD16 20mg） in Alzheimer Disease, sponsored by South China Center For Innovative Pharmaceuticals. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by South China Center For Innovative Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 3 years 8 months after the study started (first participant enrolled Jun 2019, registered Mar 2023).

Phase: Phase 1
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

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 studied

Alzheimer Disease

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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 16 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

South China Center For Innovative Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion Criteria:

Healthy subjects were aged 18-45 years (including boundary values), male and female.
Weight ≥50kg (male) or ≥45kg (female), and body mass index (BMI) of 19-24kg/m2 (including the boundary values at both ends).
Have fully understood this study, voluntarily participated in it, and signed the Informed Consent.
Subjects are able to communicate well with researchers and complete the study according to protocol.
The subjects were deemed to be in good health based on physical examination, medical history, vital signs, electrocardiogram, chest X-ray, abdominal ultrasound, and laboratory tests.
Subject (including partner) is willing to have no pregnancy plan for the next 30 days (female subject) or 90 days (male subject) and is willing to use effective contraception.

Exclusion Criteria:

Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.
The patient has symptoms or related history of any serious disease, including but not limited to heart, liver, kidney, or other acute or chronic digestive tract or respiratory tract diseases, as well as diseases of the blood, endocrine, neurological, psychiatric and other systems, or any other disease or physiological condition that can interfere with the study results.
A history of postural hypotension with frequent episodes.
A history of frequent nausea or vomiting due to any cause.
Any clear history of drug or food allergies, especially allergies to ingredients similar to the drugs in this study.
Have special dietary requirements and cannot comply with the uniform diet provided by the clinical research center.
Previous drug abuse history or positive urine drug screening during screening period.
Smokers who smoked more than 5 cigarettes a day in the 3 months before the test.
Heavy drinkers or regular drinkers in the 6 months prior to the study screening, who drank more than 14 units of alcohol per week (1 unit of alcohol ≈360 mL beer or 45 mL 40% spirits or 150 mL wine) or had a positive alcohol breath test during the screening period.
Excessive consumption of tea, coffee (more than 6 cups) and/or caffeinated beverages (more than 1L) per day.
Take food or drink rich in xanthine, grapefruit or alcohol, caffeine (e.g., dragon fruit, mango, grapefruit, chocolate, coffee or tea) within 48 hours before administration.
Surgical procedures, transfusions of blood or blood components in the month prior to study screening.
Blood loss or donation of more than 400 mL in the 2 months prior to screening.
Participated in other clinical studies and took experimental drugs within 3 months prior to study screening.
Study participants who had received any medication in the 28 days prior to screening.
Pregnant or lactating women or women who have had unprotected sex within 14 days.
Those unable to complete the study for other reasons or deemed unsuitable for inclusion by the researcher.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Experimental
High-fat diet group
A single dose of AD16 tablets was taken orally after a high fat diet
Other: high-fat diet group（AD16 20mg）
Experimental
Fasting group
A single dose of AD16 tablets was taken orally under fasting conditions
Other: fasted group（AD16 20mg）

Interventions

Otherhigh-fat diet group（AD16 20mg）
AD16 was administered with 240 mL water 30 minutes after the subjects ate a high-fat, high-calorie food.
Otherfasted group（AD16 20mg）
Subjects took AD16 on an empty stomach and fasted within 4 hours after taking the drug.

What researchers measure

Primary outcomes

Cmax of AD16
Maximum (peak) plasma drug concentration
Time frame: Up to Day 10
AUC 0-t of AD16
Area under the plasma concentration-time curve(AUC) from time zero to time t
Time frame: Up to Day 10
AUC 0-∞ of AD16
Area under the plasma concentration-time curve(AUC) from time zero to infinity
Time frame: Up to Day 10
t1/2 of AD16
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Time frame: Up to Day 10
Tmax of AD16
Time to reach the maximum (peak) plasma concentration following drug administration
Time frame: Up to Day 10
CL/F of AD16
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).
Time frame: Up to Day 10
Vd/F of AD16
Apparent volume of distribution after non-intravenous administration
Time frame: Up to Day 10
MRT of AD16
Mean residence time(MRT)
Time frame: Up to Day 10
λz of AD16
Terminal disposition rate constant/terminal rate constant
Time frame: Up to Day 10

Secondary outcomes

Adverse events
The number of adverse events
Time frame: day-7 to day 10
Serious adverse events
The number of serious adverse events
Time frame: day-7 to day 10
Number of participants with abnormal laboratory test results
Laboratory tests include blood routine, blood biochemistry, coagulation function and urine routine
Time frame: 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.
Time frame: day-7 to day3 and day7 to day10
Number of participants with abnormal 12- Lead ECG readings
abnormal 12- Lead ECG
Time frame: 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.
Time frame: day-7 to day-1 and day10
Concomitant medication
Any concomitant medication
Time frame: Up to Day 10

Study locations

1 site

The Central South University Xiang Ya Hospital
Changsha, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05787041
Lead sponsor: South China Center For Innovative Pharmaceuticals
Collaborators: Xiangya Hospital of Central South University
Responsible party: Sponsor
First posted: Mar 28, 2023
Start date: Jun 14, 2019
Primary completion: Dec 14, 2019
Completion: Dec 14, 2019
Last update: Dec 1, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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