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Will a new pill formula absorb the same? a trial puts it to the test

NCT ID NCT07756996

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial checks whether a new strength of ammoxetine hydrochloride enteric-coated tablets works the same as the original version in healthy adults. It also looks at how a high-fat meal affects the drug's absorption. Participants take single doses of both formulations, and researchers measure drug levels in the blood to compare them.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ammoxetine hydrochloride enteric-coated tablets (new formulation)
What this could lead to
If the new tablet is shown to be equivalent, it could become a more convenient or cost-effective version of the medication.
What could go wrong
This is an early-stage trial in healthy volunteers, so results may not predict effects in patients. The new formulation might not match the original, and food could change absorption unexpectedly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged 18 \~65 years (inclusive), male or female; 2. 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); 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 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; 5. Participants who voluntarily sign the informed consent form and are willing to comply with the protocol to complete the study. 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 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; 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 investigational 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Suzhou Municipal Hospital

    RECRUITING

    Suzhou, Jiangsu, 215000, China

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