Healthy ParticipantsPhase 1NCT07756996
Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Participants.
A Phase 1 study testing Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) and Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation) in people with Healthy Participants, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine hydrochloride Enteric-coated Tablets in Healthy Participants.The study is composed of 2 parts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) and Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 ~65 years (inclusive), male or female;
- Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m2 (inclusive);
- Participants with normal results or abnormal results without clinical significance in medical history, vital signs, physical examination, laboratory tests (including hematology, blood biochemistry, urinalysis, coagulation function, and related tests), chest X-ray, and other examinations.
- Participants and their partners must use effective non-hormonal contraceptive measures (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks before screening until 6 months after the end of the study, unless they have already undergone permanent sterilization (e.g., bilateral tubal ligation, vasectomy, etc.). Participants must also refrain from donating sperm or eggs;
- Participants who voluntarily sign the informed consent form and are willing to comply with the protocol to complete the study.
Who cannot join
- Participants with a history of allergic constitution (allergic to two or more drugs, foods, or pollens);
- Participants with psychiatric disorders, hepatic or renal dysfunction, gastrointestinal disorders, neurological disorders, or other systemic diseases;
- Participants with orthostatic hypotension (a decrease in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg upon standing compared to the supine position);
- Participants with a QTcF interval exceeding the upper limit of normal (males >450 ms or females >470 ms) on 12-lead ECG, or clinically significant abnormalities on a ECG as judged by the investigator, or a history of arrhythmia, syncope associated with arrhythmia, use of a cardiac pacemaker, or other cardiac conditions. Note: Cardiac conditions include, but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, 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 cardiac death;
- Heavy smokers or heavy drinkers (consumption of 14 units of alcohol per week within 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; smoking ≥5 cigarettes per day) or those with a history of other substance or drug abuse within the past year;
- Participants with a positive alcohol breath test or positive urine drug screen at screening;
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- Participants with blood donation or blood loss exceeding 200 mL within 8 weeks prior to screening;
- Participants who have participated in another clinical trial of an investigational drug within 3 months prior to screening;
- Participants who habitually consumed excessive caffeinated beverages or foods within 4 weeks prior to screening (e.g., coffee, tea, chocolate, cola, energy drinks) with a daily caffeine intake 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 can of energy drink = 85 g of chocolate);
- Participants who used strong or moderate inhibitors of the drug-metabolizing enzyme (CYP2D6) within 4 weeks prior to screening
- Participants who habitually consumed dragon fruit, mango, grapefruit, pomelo, sour orange, starfruit, pomegranate, or food/beverages prepared from these fruits within 7 days prior to screening;
- Participants who used prescription drugs, over-the-counter drugs, herbal products, vitamins, or minerals within 2 weeks prior to screening, or failed to complete at least 5 half-lives of elimination for previously used drugs, whichever is longer;
- Participants who used any psychotropic drugs or psychoactive substances within 1 year prior to screening (psychoactive substances include central nervous system depressants, stimulants, hallucinogens, opioids, volatile solvents, novel psychoactive substances, etc.);
- Pregnant or lactating women, or female participants with a positive pregnancy test at screening;
- Participants with a history of surgery that affects the in vivo disposition of drugs, or any surgery within 3 months prior to screening, or planned surgery during the study period;
- Participants who have hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption (history of diarrhea after drinking milk);
- Participants with any other condition deemed by the investigator as unsuitable for participation in this study, or withdrawal of consent for personal reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000
Mengdie, Ph.D, 86-13915574700, cmd_1988@163.com
About this study
Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine hydrochloride Enteric-coated Tablets in Healthy Participants.The study is composed of 2 parts. Part 1 is a bioequivalence study with administration 1.5 hours after a high-fat meal, using a randomized, open-label, single-dose, four-period fully replicated design. Part 2 is a food effect study using a single-center, open-label, single-dose, two-period crossover design.
- Conditions
- Healthy Participants
- Being tested
- Ammoxetine hydrochloride Enteric-coated Tablets(new formulation), Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ammoxetine hydrochloride Enteric-coated Tablets(new formulation)Drug
oral administration.
Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)Drug
oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A of bioequivalence study. | Experimental | In Period 1, subjects receive the new formulation; in Period 2, the Phase III formulation; in Period 3, the new formulation; and in Period 4, the Phase III formulation. Receives: Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation); Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation) |
| Sequence B of bioequivalence study. | Experimental | In Period 1, subjects receive the Phase III formulation; in Period 2, the new formulation; in Period 3, the Phase III formulation; and in Period 4, the new formulation Receives: Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation); Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation) |
| Sequence C of food effect study. | Experimental | In Period 1, the new formulation is administered under fasting conditions; in Period 2, the new formulation is administered 1 hour after a high-fat meal. Receives: Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) |
| Sequence D of food effect study. | Experimental | In Period 1, the new formulation is administered 1 hour after a high-fat meal; in Period 2, the new formulation is administered under fasting conditions. Receives: Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Maximum concentration (Cmax)
Measured: Up to 60 hours
Area under the concentration-time curve (AUC)
Measured: Up to 60 hours
Secondary outcomes (6)
Half-Life (t1/2)
Measured: Up to 60 hours
Absorption lag time(Tlag)
Measured: Up to 60 hours
Time to maximum plasma concentration(Tmax)
Measured: Up to 60 hours
Apparent volume of distribution during the terminal phase (Vz/F)
Measured: Up to 60 hours
Apparent total clearance (CL/F)
Measured: Up to 60 hours
The Incidenceof adverse events (AEs)
Measured: Up to 60 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start15 Jul 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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
- Model description
- Drug:Ammoxetine hydrochloride Enteric-coated Tablets Other: N/A
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
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
- NCT07756996
- Sponsor's protocol ID
- HA1406-014
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Participants.
- ClinicalTrials.gov ID
- NCT07756996
- Acronym / sponsor ID
- HA1406-014
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 Aug 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.
Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine hydrochloride Enteric-coated Tablets in Healthy Participants.The study is composed of 2 parts. Part 1 is a bioequivalence study with administration 1.5 hours after a high-fat meal, using a randomized, open-label, single-dose, four-period fully replicated design. Part 2 is a food effect study using a single-center, open-label, single-dose, two-period crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Drug:Ammoxetine hydrochloride Enteric-coated Tablets Other: N/A
| Arm | Type | Receives |
|---|---|---|
| Sequence A of bioequivalence study. | Experimental | Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation), Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)In Period 1, subjects receive the new formulation; in Period 2, the Phase III formulation; in Period 3, the new formulation; and in Period 4, the Phase III formulation. |
| Sequence B of bioequivalence study. | Experimental | Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation), Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)In Period 1, subjects receive the Phase III formulation; in Period 2, the new formulation; in Period 3, the Phase III formulation; and in Period 4, the new formulation |
| Sequence C of food effect study. | Experimental | Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation)In Period 1, the new formulation is administered under fasting conditions; in Period 2, the new formulation is administered 1 hour after a high-fat meal. |
| Sequence D of food effect study. | Experimental | Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation)In Period 1, the new formulation is administered 1 hour after a high-fat meal; in Period 2, the new formulation is administered under fasting conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 ~65 years (inclusive), male or female;
- Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19.0 ~ 28.0 kg/m2 (inclusive);
- Participants with normal results or abnormal results without clinical significance in medical history, vital signs, physical examination, laboratory tests (including hematology, blood biochemistry, urinalysis, coagulation function, and related tests), chest X-ray, and other examinations.
- Participants and their partners must use effective non-hormonal contraceptive measures (e.g., condoms, inert intrauterine devices, etc.) from 2 weeks before screening until 6 months after the end of the study, unless they have already undergone permanent sterilization (e.g., bilateral tubal ligation, vasectomy, etc.). Participants must also refrain from donating sperm or eggs;
- Participants who voluntarily sign the informed consent form and are willing to comply with the protocol to complete the study.
Key exclusion criteria (17 listed)
- Participants with a history of allergic constitution (allergic to two or more drugs, foods, or pollens);
- Participants with psychiatric disorders, hepatic or renal dysfunction, gastrointestinal disorders, neurological disorders, or other systemic diseases;
- Participants with orthostatic hypotension (a decrease in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg upon standing compared to the supine position);
- Participants with a QTcF interval exceeding the upper limit of normal (males >450 ms or females >470 ms) on 12-lead ECG, or clinically significant abnormalities on a ECG as judged by the investigator, or a history of arrhythmia, syncope associated with arrhythmia, use of a cardiac pacemaker, or other cardiac conditions. Note: Cardiac conditions include, but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, 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 cardiac death;
- Heavy smokers or heavy drinkers (consumption of 14 units of alcohol per week within 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; smoking ≥5 cigarettes per day) or those with a history of 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 Tablets(new formulation)oral administration. | Drug | Sequence A of bioequivalence study., Sequence B of bioequivalence study., Sequence C of food effect study., Sequence D of food effect study. |
| Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)oral administration. | Drug | Sequence A of bioequivalence study., Sequence B of bioequivalence study. |
Primary outcome
Plasma Maximum concentration (Cmax)
Time frame: Up to 60 hours
Area under the concentration-time curve (AUC)
Time frame: Up to 60 hours
6 secondary outcomes
Half-Life (t1/2)
Time frame: Up to 60 hours
Absorption lag time(Tlag)
Time frame: Up to 60 hours
Time to maximum plasma concentration(Tmax)
Time frame: Up to 60 hours
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Up to 60 hours
Apparent total clearance (CL/F)
Time frame: Up to 60 hours
The Incidenceof adverse events (AEs)
Time frame: Up to 60 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
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(new formulation) and Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation) 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 17 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: looking for participants now, as of the sponsor's last update on 11 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Maximum concentration (Cmax) (time frame: Up to 60 hours). The study lists 2 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 11 Aug 2026.