Food-effect Study of Ammoxetine Hydrochloride Enteric-coated Tablets

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

This study is a single-center, randomized, open-label, two-period crossover design to evaluate the effect of food on the pharmacokinetic profile of ammoxetine hydrochloride enteric-coated tablets.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 14
• 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 26.0 kg/m² (inclusive);
3. Results of medical history, vital signs, physical examination, and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and other relevant tests) are normal or abnormal but without clinical significance;
4. Subjects and their partners must use effective non-hormonal contraceptive methods (e.g., condoms, non-hormonal intrauterine devices) from 2 weeks prior to screening until 6 months after the study completion, except for those who have already adopted permanent contraceptive measures (e.g., bilateral tubal ligation, vasectomy). Donation of sperm or eggs is also prohibited during this period;
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 clinically significant abnormalities confirmed by comprehensive examinations including medical history, physical examination, electrocardiogram, and chest X-ray;
4. Subjects with systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg during the screening period;
5. Subjects with orthostatic hypotension;
6. Subjects with corrected QT interval (QTc) ≥ 450 ms (male) or ≥ 470 ms (female), or a history of prolonged QTc interval;
7. 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;
8. Subjects who have donated or lost more than 400 mL of blood within the 8 weeks prior to screening;
9. Subjects who have participated in other clinical trials within the 3 months prior to screening;
10. 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;
11. 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, omeprazole, or grapefruit
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 who have already participated in this trial;
16. 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

2

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 40mg of ammoxetine hydrochloride enteric-coated tablets; Drug: Ammoxetine hydrochloride enteric-coated tablets; Single-dose of 40 mg of ammoxetine hydrochloride enteric-coated tablets
Experimental: Fed conditions; Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in fed condition.	Drug: Ammoxetine hydrochloride enteric-coated tablets; Single-dose of 40mg of ammoxetine hydrochloride enteric-coated tablets; Drug: Ammoxetine hydrochloride enteric-coated tablets; Single-dose of 40 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): February 8, 2023
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): April 4, 2023

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: HA1406-004

Drug and device information, study documents

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