Healthy ParticipantsPhase 1NCT07694869
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Moderate Renal Impairment and Normal Renal Function
A Phase 1 study testing ammoxetine hydrochloride enteric-coated tablets in people with Healthy Participants and Participants With Moderate Renal Impairment, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical trial evaluating the pharmacokinetic characteristics of ammoxetine hydrochloride enteric-coated tablets in participants with normal renal function and moderate renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Participants With Moderate Renal Impairment
- 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
- 16 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2026to 11 Nov 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for participants with abnormal liver function (all 7 criteria must be met):
- Adults aged 18 ~ 75 years (inclusive), regardless of gender
- Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19 ~ 32 kg/m2 (inclusive);
- Participants whose medical history, vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, infectious disease screening, and other relevant tests), Chest X-ray and other examination must be deemed suitable for participation in this study by the investigator;
- Participants and their partners must use effective contraception (such as condoms or an intrauterine device) from 2 weeks prior to screening until 6 months after the end of the study, unless they have already undergone permanent sterilization procedures, such as bilateral tubal ligation or vasectomy; furthermore, they must not donate sperm or eggs.
- Participants who voluntarily sign the informed consent form and agree to cooperate in completing the trial according to the protocol.
Who cannot join
- Participants meeting any of the following criteria will be excluded from this trial:
- All participants:
- Individuals with a history of allergies (allergic to two or more drugs, foods, or pollens);
- Individuals with major psychiatric disorders, neurological disorders, or other systemic diseases that the investigator deems may affect trial results;
- Participants who have had a severe infection or trauma within 4 weeks prior to screening, or who have undergone surgery (e.g., gastrectomy) that may affect drug absorption, distribution, metabolism, or excretion, or who are scheduled for surgery or hospitalization for other reasons during the trial period;
- Participants who have experienced any of the following cardiovascular or cerebrovascular events within 6 months prior to screening: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (NYHA Class II-IV), a history of clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or left ventricular dysfunction; transient ischemic attack or cerebrovascular accident (e.g., stroke);history of coronary artery bypass grafting or coronary stenting, or other cardiovascular diseases, and who are deemed unsuitable for participation in this clinical trial by the investigator;
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- Participants who have participated in other drug clinical trials within 3 months prior to screening (as determined by the date of administration);
- Smokers or heavy drinkers (consumption of 14 units of alcohol per week within 4 weeks prior to screening: 1 unit = 285 mL of beer, 25 mL of spirits, or 150 mL of wine; smoking ≥5 cigarettes per day) or those with a history of substance or drug abuse within the past year;
- Individuals who have donated or lost more than 200 mL of blood within 8 weeks prior to screening;
- Individuals with a positive breathalyzer test for alcohol or a positive urine test for drug abuse during the screening period;
- Individuals who habitually consumed excessive amounts of caffeinated beverages or foods within 4 weeks prior to screening. Examples include coffee, tea, chocolate, cola, and Red Bull (daily caffeine intake should not exceed 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 of chocolate;
- Participants who used strong or moderate inhibitors of liver enzymes (CYP2D6) within 4 weeks prior to screening;
- Pregnant or breastfeeding women, or female participants who test positive for pregnancy during the screening period;
- Participants with QTcF on a 12-lead ECG exceeding the upper limit of normal (>450 ms for males or >470 ms for females), or those with ECG findings deemed clinically significant by the study physician, history of arrhythmia, syncope related to arrhythmia, or those using of a cardiac pacemaker or other cardiac-related conditions. Note: 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 death;
- Individuals 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);
- Individuals with a history of dysphagia or any gastrointestinal disease affecting drug absorption;
- Patients with concurrent viral infections (anti-HCV positive, anti-HIV positive, HBsAg positive) or concurrent syphilis infection;
- Participants with CYP2D6 poor metabolizer;
- Participants deemed by the investigator to be unsuitable for this clinical trial for other reasons.
- Participants with renal impairment:
- Participants who have undergone a kidney transplant or who require hemodialysis during the study;
- Participants with urinary tract obstruction or difficulty urinating, urinary incontinence, or anuria;
- Participants with acute diseases affecting any organ other than the condition causing renal impairment, or those with chronic diseases that may affect the pharmacokinetics of the study drug (e.g., hepatic impairment), who are deemed unsuitable for this trial by the investigator;
- Participants with coagulation abnormalities (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 × ULN), or a history of clinically significant bleeding within the 3 months prior to screening, or a clear predisposition to bleeding, such as gastrointestinal bleeding or hemorrhagic gastric ulcers, or current treatment with thrombolytic or anticoagulant therapy;
- Participants with systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg; pulse rate >100 bpm, during the time of screening;
- Patients with acute hepatitis, chronic liver disease, or levels of ALT, AST, or GGT exceeding twice the upper limit of normal (ULN), or total bilirubin exceeding 1.5 times the ULN;
- At screening, patients with gallbladder disease that is determined by the investigator to affect bile excretion;
- Patients with a history of malignancy, psychiatric disorders, anxiety, or epilepsy;
- Participants with normal renal function:
- Participants who have used any prescription drugs, over-the-counter medications, or traditional Chinese medicine (herbal medicines, proprietary Chinese medicines) within 2 weeks prior to screening.
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
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Huan Zhou, Ph.D, +86 13665527160, zhouhuanbest@vip.163.com
About this study
Official title: A Single-Center, Non-Randomized, Open-Label, Parallel-Group Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics of Multiple Doses of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Moderate Renal Impairment and Normal Renal Function
This study is a single-center, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical trial evaluating the pharmacokinetic characteristics of ammoxetine hydrochloride enteric-coated tablets in participants with normal renal function and moderate renal impairment. The study enrolls 16 participants divided into two groups: Group A (participants with normal renal function) and Group B (participants with moderate renal impairment). Participants in both groups receive 60 mg of ammoxetine hydrochloride enteric-coated tablets daily at 1 hour after meals, from day 1 to day 6. Blood samples for pharmacokinetic (PK) analysis, urine samples, and safety parameters are collected before and after dosing according to the trial protocol.
- 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
Oral administration; 60 mg
| Study group | Role | What they receive |
|---|---|---|
| Moderate Renal Insufficiency Group | Experimental | Not described Receives: Drug: ammoxetine hydrochloride enteric-coated tablets |
| Normal renal function Group | Experimental | Not described Receives: Drug: ammoxetine hydrochloride enteric-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss)
Measured: Within 96 hours after the last dose
Maximum concentration observed during dosing interval at steady-state (Cmax,ss)
Measured: Within 96 hours after the last dose
Secondary outcomes (5)
The incidence of adverse events (AEs)
Measured: Up to 96 hours after the last dose
Minimum concentration observed during dosing interval at steady-state (Cmin,ss)
Measured: Within 96 hours after the last dose
Half-Life (t1/2)
Measured: Within 96 hours after the last dose
Mean concentration observed during dosing interval at steady-state (Cav,ss)
Measured: Within 96 hours after the last dose
Renal clearance(CLr)
Measured: Up to 96 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start10 May 2026
- Primary completion10 Oct 2026 (estimated)
- Study completion11 Nov 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Drug: ammoxetine hydrochloride enteric-coated tablets
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT07694869
- Sponsor's protocol ID
- HA1406-013
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Non-Randomized, Open-Label, Parallel-Group Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics of Multiple Doses of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Moderate Renal Impairment and Normal Renal Function
- ClinicalTrials.gov ID
- NCT07694869
- Acronym / sponsor ID
- HA1406-013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2026 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 10 Jul 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, non-randomized, open-label, parallel-group, multiple-dose Phase I clinical trial evaluating the pharmacokinetic characteristics of ammoxetine hydrochloride enteric-coated tablets in participants with normal renal function and moderate renal impairment. The study enrolls 16 participants divided into two groups: Group A (participants with normal renal function) and Group B (participants with moderate renal impairment). Participants in both groups receive 60 mg of ammoxetine hydrochloride enteric-coated tablets daily at 1 hour after meals, from day 1 to day 6. Blood samples for pharmacokinetic (PK) analysis, urine samples, and safety parameters are collected before and after dosing according to the trial protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Drug: ammoxetine hydrochloride enteric-coated tablets
| Arm | Type | Receives |
|---|---|---|
| Moderate Renal Insufficiency Group | Experimental | Drug: ammoxetine hydrochloride enteric-coated tablets |
| Normal renal function Group | Experimental | Drug: ammoxetine hydrochloride enteric-coated tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inclusion criteria for participants with abnormal liver function (all 7 criteria must be met):
- Adults aged 18 ~ 75 years (inclusive), regardless of gender
- Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), body mass index (BMI) in the range of 19 ~ 32 kg/m2 (inclusive);
- Participants whose medical history, vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, infectious disease screening, and other relevant tests), Chest X-ray and other examination must be deemed suitable for participation in this study by the investigator;
- Participants and their partners must use effective contraception (such as condoms or an intrauterine device) from 2 weeks prior to screening until 6 months after the end of the study, unless they have already undergone permanent sterilization procedures, such as bilateral tubal ligation or vasectomy; furthermore, they must not donate sperm or eggs.
Key exclusion criteria (30 listed)
- Individuals with a history of allergies (allergic to two or more drugs, foods, or pollens);
- Individuals with major psychiatric disorders, neurological disorders, or other systemic diseases that the investigator deems may affect trial results;
- Participants who have had a severe infection or trauma within 4 weeks prior to screening, or who have undergone surgery (e.g., gastrectomy) that may affect drug absorption, distribution, metabolism, or excretion, or who are scheduled for surgery or hospitalization for other reasons during the trial period;
- Participants who have experienced any of the following cardiovascular or cerebrovascular events within 6 months prior to screening: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (NYHA Class II-IV), a history of clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, or left ventricular dysfunction; transient ischemic attack or cerebrovascular accident (e.g., stroke);history of coronary artery bypass grafting or coronary stenting, or other cardiovascular diseases, and who are deemed unsuitable for participation in this clinical trial by the investigator;
- Participants who have participated in other drug clinical trials within 3 months prior to screening (as determined by the date of administration);
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 tabletsOral administration; 60 mg | Drug | Moderate Renal Insufficiency Group, Normal renal function Group |
Primary outcome
Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss)
Time frame: Within 96 hours after the last dose
Maximum concentration observed during dosing interval at steady-state (Cmax,ss)
Time frame: Within 96 hours after the last dose
5 secondary outcomes
The incidence of adverse events (AEs)
Time frame: Up to 96 hours after the last dose
Minimum concentration observed during dosing interval at steady-state (Cmin,ss)
Time frame: Within 96 hours after the last dose
Half-Life (t1/2)
Time frame: Within 96 hours after the last dose
Mean concentration observed during dosing interval at steady-state (Cav,ss)
Time frame: Within 96 hours after the last dose
Renal clearance(CLr)
Time frame: Up to 96 hours after the last dose
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 10 Jul 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 in people with Healthy Participants and Participants With Moderate Renal Impairment, 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 6 inclusion and 30 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 10 Jul 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?
Area under the concentration vs. time curve for one dosing interval at steady-state (AUCtau,ss) (time frame: Within 96 hours after the last dose). 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 10 Jul 2026.