A Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

A Single-dose, Randomized, Open-label, Three-sequence, Three-period Crossover Clinical Trial to Evaluate the Effect of High-fat and Low-fat Meals on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects.

This study is a single-dose, randomized, open-label, three-sequence, three-period crossover clinical trial to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of ammoxetine hydrochloride enteric-coated tablets in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Ammoxetine hydrochloride enteric-coated tablets

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050035
      • The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: 18-45 years (inclusive), both male and female subjects;
2. Body weight ≥ 45.0 kg (female) or 50.0 kg (male), with body mass index (BMI) between 19.0 kg/m² and 28.0 kg/m² (inclusive);
3. Results of medical history, vital signs, physical examination, laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and other relevant tests), and chest X-ray examination are normal or abnormal but without clinical significance;
4. Subjects with corrected QT interval using Fridericia's formula exceeding the upper limit of normal (male ≥450 ms or female ≥460 ms), or with abnormal electrocardiogram findings considered clinically significant by the study physician, or with a history of arrhythmias or syncope associated with arrhythmias, or using a pacemaker.
5. Voluntarily sign the informed consent form and be willing to comply with the protocol to complete the study.

Exclusion Criteria:

1. Subjects with a history of allergies (allergic to two or more types of drugs, foods, or pollen);
2. Subjects suffering from psychiatric disorders, hepatic or renal diseases, gastrointestinal diseases, neurological diseases, or other systemic diseases;
3. Subjects with orthostatic hypotension;
4. Subjects with a 12-lead ECG QTcF interval exceeding the upper limit of normal (male ≥450 ms or female ≥460 ms), or with abnormal ECG findings considered clinically significant by the study physician, or with a history of arrhythmias or syncope associated with arrhythmias, or using a pacemaker. Note: Diseases include, but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, premature atrial contractions, premature ventricular contractions, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden death;
5. Subjects with a history of smoking or alcohol abuse (consumption of 14 units of alcohol per week within the 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; daily smoking ≥ 5 cigarettes) or other substance or drug abuse within the past year;
6. Subjects with a positive alcohol breath test or positive urine drug screen during the screening period;
7. Subjects who have donated or lost more than 400 mL of blood within the 8 weeks prior to screening;
8. Subjects who have participated in other drug clinical trials within the 3 months prior to screening;
9. Subjects who habitually consume excessive amounts of caffeinated beverages or foods within the 4 weeks prior to screening, such as coffee, tea, chocolate, cola, or Red Bull (daily caffeine intake not exceeding 6 units). 1 caffeine unit = 1 cup of coffee (177.4 mL) = 2 cans of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup of energy drink = 85 g chocolate;
10. Subjects who have used medications that alter the activity of liver enzymes (Cytochrome P450 2C19 and Cytochrome P450 3A4) within the 4 weeks prior to screening, such as dexamethasone, ketoconazole, rifampicin, or omeprazole;
11. Subjects who have consumed dragon fruit, mango, shaddock, grapefruit, lime, star fruit, pomegranate, or any foods or beverages prepared from these fruits within the 7 days prior to screening;
12. Subjects who have used prescription drugs, over-the-counter medications (except for occasional use of acetaminophen and nasal sprays), herbal remedies, vitamins, or minerals within the 2 weeks prior to screening, or for whom the washout period of prior medications (based on the longest half-life) is less than 5 half-lives before screening;
13. Subjects using any psychiatric medications or psychoactive substances;
14. Pregnant or lactating women, or female subjects with a positive pregnancy test during the screening period;
15. Subjects considered by the investigator to have any factors that make them unsuitable for participation in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting conditions; Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in fasting condition.	Drug: Ammoxetine hydrochloride enteric-coated tablets; Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets
Experimental: High-fat fed conditions; Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in high-fat fed condition.	Drug: Ammoxetine hydrochloride enteric-coated tablets; Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets
Experimental: Low-fat fed conditions; Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in low-fat fed condition.	Drug: Ammoxetine hydrochloride enteric-coated tablets; Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters	Maximum plasma concentration (Cmax)	up to 48 hours
PK parameters	Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)	up to 48 hours
PK parameters	Area under the concentration-time curve from zero to the last measurable time (AUC0-t)	up to 48 hours

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): June 17, 2024
• Study Completion (Actual): August 2, 2024

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HA1406-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No