Will a new pill formula absorb the same? a trial puts it to the test
NCT ID NCT07756996
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy participants are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGSuzhou, Jiangsu, 215000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Does it matter where you inject? scientists test Weight-Loss drug in arm, thigh, and belly
- New drug RO7830698 put to the test for COPD
- Three pill versions of one drug go head to head in the bloodstream
- Pfizer tests RSV vaccine aimed at older adults
- Radioactive tracer maps where a new drug goes in the body
- Radioactive tag lets scientists follow an experimental drug through the human body