Healthy ParticipantsPhase 1NCT07508501

Food-effect Study of Ammoxetine Hydrochloride Enteric-coated Tablets

A Phase 1 study testing Ammoxetine hydrochloride enteric-coated tablets in people with Healthy Participants, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Ammoxetine hydrochloride enteric-coated tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteChina
Study dates: 8 Feb 2023to 4 Apr 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 16Show fewer

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;
Subjects considered by the investigator to have any factors that make them unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: 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.

Conditions: Healthy Participants
Being tested: Ammoxetine hydrochloride enteric-coated tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07508501
Study group	Role	What they receive
Fasting conditions	Experimental	Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in fasting condition. Receives: 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. Receives: Drug: Ammoxetine hydrochloride enteric-coated tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

PK parameters
Maximum plasma concentration (Cmax)
Measured: up to 48 hours
PK parameters
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf)
Measured: up to 48 hours
PK parameters
Area under the concentration-time curve from zero to the last measurable time (AUC0-t)
Measured: up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 20234 Apr 2023

First posted2 Apr 2026
Study start8 Feb 2023
Primary completion24 Feb 2023
Study completion4 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07508501
Sponsor's protocol ID: HA1406-004
Status last verified: Mar 2026
First submitted: 24 Mar 2026
Last updated: 2 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects
ClinicalTrials.gov ID: NCT07508501
Acronym / sponsor ID: HA1406-004
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Feb 2023 (actual)
Primary completion: 24 Feb 2023 (actual)
Study completion: 4 Apr 2023 (actual)
First posted: 2 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fasting conditions	Experimental	Drug: Ammoxetine hydrochloride enteric-coated tabletsPeriod in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in fasting condition.
Fed conditions	Experimental	Drug: Ammoxetine hydrochloride enteric-coated tabletsPeriod in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in fed condition.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ammoxetine hydrochloride enteric-coated tabletsSingle-dose of 40mg of ammoxetine hydrochloride enteric-coated tablets	Drug	Fasting conditions
Ammoxetine hydrochloride enteric-coated tabletsSingle-dose of 40 mg of ammoxetine hydrochloride enteric-coated tablets	Drug	Fed conditions

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ammoxetine hydrochloride enteric-coated tablets in people with Healthy Participants, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK parameters (time frame: up to 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07508501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.