Healthy ParticipantsPhase 1NCT07508462
A Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects
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.
Trial summary
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. 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
- 18 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 2 Aug 2024
- 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 28.0 kg/m² (inclusive);
- 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;
- 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.
- 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 orthostatic hypotension;
- 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;
- 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 with a positive alcohol breath test or positive urine drug screen during the screening period;
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- 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 drug 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, or omeprazole;
- 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;
- 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 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
About this study
Official title: 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.
- 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 60 mg of ammoxetine hydrochloride enteric-coated tablets
Ammoxetine hydrochloride enteric-coated tabletsDrug
Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets
Ammoxetine hydrochloride enteric-coated tabletsDrug
Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets
| 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 |
| High-fat fed conditions | Experimental | Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in high-fat fed condition. Receives: Drug: Ammoxetine hydrochloride enteric-coated tablets |
| Low-fat fed conditions | Experimental | Period in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in low-fat 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.
- First posted2 Apr 2026
- Study start30 May 2024
- Primary completion17 Jun 2024
- Study completion2 Aug 2024
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508462
- Sponsor's protocol ID
- HA1406-006
- 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
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 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.
- ClinicalTrials.gov ID
- NCT07508462
- Acronym / sponsor ID
- HA1406-006
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 2 Aug 2024 (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-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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| 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. |
| High-fat fed conditions | Experimental | Drug: Ammoxetine hydrochloride enteric-coated tabletsPeriod in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in high-fat fed condition. |
| Low-fat fed conditions | Experimental | Drug: Ammoxetine hydrochloride enteric-coated tabletsPeriod in which subjects receive a single oral dose of ammoxetine hydrochloride enteric-coated tablets in low-fat 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 28.0 kg/m² (inclusive);
- 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;
- 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.
- Voluntarily sign the informed consent form and be willing to comply with the protocol to complete the study.
Key exclusion criteria (15 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 orthostatic hypotension;
- 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;
- 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;
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 60 mg of ammoxetine hydrochloride enteric-coated tablets | Drug | Fasting conditions |
| Ammoxetine hydrochloride enteric-coated tabletsSingle-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets | Drug | High-fat fed conditions |
| Ammoxetine hydrochloride enteric-coated tabletsSingle-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets | Drug | Low-fat 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 15 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?
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.