Healthy Participants
Conditions
Brief 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.
Interventions
DRUGAmmoxetine hydrochloride Enteric-coated Tablets(new formulation)
oral administration.
DRUGAmmoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)
oral administration.
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Drug:Ammoxetine hydrochloride Enteric-coated Tablets Other: N/A
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Maximum concentration (Cmax) | Up to 60 hours |
| Area under the concentration-time curve (AUC) | Up to 60 hours |
Secondary
| Measure | Time frame |
|---|---|
| Half-Life (t1/2) | Up to 60 hours |
| Absorption lag time(Tlag) | Up to 60 hours |
| Time to maximum plasma concentration(Tmax) | Up to 60 hours |
| Apparent volume of distribution during the terminal phase (Vz/F) | Up to 60 hours |
| Apparent total clearance (CL/F) | Up to 60 hours |
| The Incidenceof adverse events (AEs) | Up to 60 hours |
Countries
China
Contacts
CONTACTClinical Trials Information Group officer
Outcome results
None listed