ClinicalTrials.gg
RecruitingNCT07756996Updated Aug 11, 2026

Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Participants.

A Phase 1 interventional study of Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) and Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation) in Healthy Participants, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 167 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults aged 18 \~65 years (inclusive), male or female;
  2. Body weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), (BMI) in the range of 19.0 \~ 28.0 kg/m2 (inclusive);
  3. 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.
  4. Participants and their partners must use effective non-hormonal 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;
  5. Participants who voluntarily sign the form and are willing to comply with the protocol to complete the study.

Exclusion criteria

Exclusion Criteria:

  1. Participants with a history of allergic constitution (allergic to two or more drugs, foods, or pollens);
  2. Participants with psychiatric disorders, hepatic or renal dysfunction, gastrointestinal disorders, neurological disorders, or other systemic diseases;
  3. 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);
  4. Participants with a interval exceeding the (males >450 ms or females >470 ms) on 12-lead , or 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;
  5. 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;
  6. Participants with a positive alcohol breath test or positive urine drug screen at screening;
  7. Participants with blood donation or blood loss exceeding 200 mL within 8 weeks prior to screening;
  8. Participants who have participated in another clinical trial of an drug within 3 months prior to screening;
  9. 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);
  10. Participants who used strong or moderate inhibitors of the drug-metabolizing enzyme (CYP2D6) within 4 weeks prior to screening
  11. 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;
  12. 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;
  13. 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.);
  14. Pregnant or lactating women, or female participants with a positive pregnancy test at screening;
  15. 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;
  16. Participants who have hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption (history of diarrhea after drinking milk);
  17. Participants with any other condition deemed by the investigator as unsuitable for participation in this study, or withdrawal of consent for personal reasons.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Sequence A of bioequivalence study.

    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.

    Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) · Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)

  • Experimental
    Sequence B of bioequivalence study.

    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

    Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) · Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)

  • Experimental
    Sequence C of food effect study.

    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.

    Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation)

  • Experimental
    Sequence D of food effect study.

    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.

    Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation)

Interventions

  • DrugAmmoxetine hydrochloride Enteric-coated Tablets(new formulation)

    oral administration.

  • DrugAmmoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)

    oral administration.

06

What researchers measure

Primary outcomes

  1. Plasma Maximum concentration (Cmax)

    Time frame: Up to 60 hours

  2. Area under the concentration-time curve (AUC)

    Time frame: Up to 60 hours

Secondary outcomes

  1. Half-Life (t1/2)

    Time frame: Up to 60 hours

  2. Absorption lag time(Tlag)

    Time frame: Up to 60 hours

  3. Time to maximum plasma concentration(Tmax)

    Time frame: Up to 60 hours

  4. Apparent volume of distribution during the terminal phase (Vz/F)

    Time frame: Up to 60 hours

  5. Apparent total clearance (CL/F)

    Time frame: Up to 60 hours

  6. The Incidenceof adverse events (AEs)

    Time frame: Up to 60 hours

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07756996
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Jul 15, 2026
Primary completion
Aug 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Aug 11, 2026

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
031169085587

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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