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
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.
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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
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)
oral administration.
oral administration.
Plasma Maximum concentration (Cmax)
Time frame: Up to 60 hours
Area under the concentration-time curve (AUC)
Time frame: Up to 60 hours
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. →