A Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of Ammoxetine Hydrochlori… (NCT07508462) | Clinical Trial Compass
CompletedPhase 1
A Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects
China18 participantsStarted 2024-05-30
Plain-language summary
This study is a single-dose, randomized, open-label, three-sequence, three-period crossover clinical trial to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of ammoxetine hydrochloride enteric-coated tablets in healthy subjects.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Age: 18-45 years (inclusive), both male and female subjects;
✓. Body weight ≥ 45.0 kg (female) or 50.0 kg (male), with body mass index (BMI) between 19.0 kg/m² and 28.0 kg/m² (inclusive);
✓. Results of medical history, vital signs, physical examination, laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and other relevant tests), and chest X-ray examination are normal or abnormal but without clinical significance;
✓. Subjects with corrected QT interval using Fridericia's formula exceeding the upper limit of normal (male ≥450 ms or female ≥460 ms), or with abnormal electrocardiogram findings considered clinically significant by the study physician, or with a history of arrhythmias or syncope associated with arrhythmias, or using a pacemaker.
✓. Voluntarily sign the informed consent form and be willing to comply with the protocol to complete the study.
Exclusion criteria
✕. Subjects with a history of allergies (allergic to two or more types of drugs, foods, or pollen);
✕. Subjects suffering from psychiatric disorders, hepatic or renal diseases, gastrointestinal diseases, neurological diseases, or other systemic diseases;
✕. Subjects with orthostatic hypotension;
✕. Subjects with a 12-lead ECG QTcF interval exceeding the upper limit of normal (male ≥450 ms or female ≥460 ms), or with abnormal ECG findings considered clinically significant by the study physician, or with a history of arrhythmias or syncope associated with arrhythmias, or using a pacemaker. Note: Diseases include, but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, premature atrial contractions, premature ventricular contractions, 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;
✕. Subjects with a history of smoking or alcohol abuse (consumption of 14 units of alcohol per week within the 4 weeks prior to screening: 1 unit = 285 mL beer, or 25 mL spirits, or 150 mL wine; daily smoking ≥ 5 cigarettes) or other substance or drug abuse within the past year;
✕. Subjects with a positive alcohol breath test or positive urine drug screen during the screening period;
✕. Subjects who have donated or lost more than 400 mL of blood within the 8 weeks prior to screening;
✕. Subjects who have participated in other drug clinical trials within the 3 months prior to screening;