Food-effect Study of Ammoxetine Hydrochloride Enteric-coated Tablets

NCT07508501 | Completed Phase 1

• 1 other identifier: HA1406-004
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Fasting conditions

EXPERIMENTAL

Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in fasting condition.

Drug: Ammoxetine hydrochloride enteric-coated tablets

Fed conditions

EXPERIMENTAL

Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in fed condition.

Drug: Ammoxetine hydrochloride enteric-coated tablets

Interventions

Ammoxetine hydrochloride enteric-coated tablets DRUG

Single-dose of 40mg of ammoxetine hydrochloride enteric-coated tablets

Fasting conditions

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-45 years (inclusive), both male and female subjects;
• 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);
• 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;
• 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;
• Voluntarily sign the informed consent form and be willing to comply with the protocol to complete the study.

You may not qualify if:

• Subjects with a history of allergies (allergic to two or more types of drugs, foods, or pollen);
• Subjects suffering from psychiatric disorders, hepatic or renal diseases, gastrointestinal diseases, neurological diseases, or other systemic diseases;
• Subjects with clinically significant abnormalities confirmed by comprehensive examinations including medical history, physical examination, electrocardiogram, and chest X-ray;
• Subjects with systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg during the screening period;
• Subjects with orthostatic hypotension;
• Subjects with corrected QT interval (QTc) ≥ 450 ms (male) or ≥ 470 ms (female), or a history of prolonged QTc interval;
• 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;
• Subjects who have donated or lost more than 400 mL of blood within the 8 weeks prior to screening;
• Subjects who have participated in other clinical trials within the 3 months prior to screening;
• 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;
• 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
• 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;
• Subjects using any psychiatric medications or psychoactive substances;
• Pregnant or lactating women, or female subjects with a positive pregnancy test during the screening period;
• Subjects who have already participated in this trial;

Sponsors & Collaborators

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

Study Sites (1)

The Fourth Hospital of Hebei Medical University ，Hebei Tumor Hospital

Shijiazhuang, Hebei, 050035, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 2, 2026
• Study Start: February 8, 2023
• Primary Completion: February 24, 2023
• Study Completion: April 4, 2023
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)