Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Participants.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Ammoxetine hydrochloride Enteric-coated Tablets(new formulation); Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 031169085587; Email: ctr-contact@cspc.cn

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • Suzhou Municipal Hospital
      • Contact: Mengdie, Ph.D; Phone Number: 86-13915574700; Email: cmd_1988@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A of bioequivalence study.; 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); oral administration.; Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation); oral administration.
Experimental: Sequence B of bioequivalence study.; 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); oral administration.; Drug: Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation); oral administration.
Experimental: Sequence C of food effect study.; 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); oral administration.
Experimental: Sequence D of food effect study.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma Maximum concentration (Cmax)	Up to 60 hours
Area under the concentration-time curve (AUC)	Up to 60 hours

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 11, 2026

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HA1406-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No