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

NCT07756996 | Recruiting Phase 1

• 1 other identifier: HA1406-014
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Plasma Maximum concentration (Cmax)

  Up to 60 hours

• Area under the concentration-time curve (AUC)

  Up to 60 hours

Secondary Outcomes (6)

• 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

Study Arms (4)

Sequence A of bioequivalence study.

EXPERIMENTAL

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)

Sequence B of bioequivalence study.

EXPERIMENTAL

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)

Sequence C of food effect study.

EXPERIMENTAL

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)

Sequence D of food effect study.

EXPERIMENTAL

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)

Interventions

Ammoxetine hydrochloride Enteric-coated Tablets(new formulation) DRUG

oral administration.

Sequence A of bioequivalence study.; Sequence B of bioequivalence study.; Sequence C of food effect study.; Sequence D of food effect study.

Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation) DRUG

oral administration.

Sequence A of bioequivalence study.; Sequence B of bioequivalence study.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 \~65 years (inclusive), male or female;
• 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);
• 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.
• 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;
• Participants who voluntarily sign the informed consent form and are willing to comply with the protocol to complete the study.

You may not qualify if:

• Participants with a history of allergic constitution (allergic to two or more drugs, foods, or pollens);
• Participants with psychiatric disorders, hepatic or renal dysfunction, gastrointestinal disorders, neurological disorders, or other systemic diseases;
• 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);
• 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;
• 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;
• Participants with a positive alcohol breath test or positive urine drug screen at screening;
• Participants with blood donation or blood loss exceeding 200 mL within 8 weeks prior to screening;
• Participants who have participated in another clinical trial of an investigational drug within 3 months prior to screening;
• 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);
• Participants who used strong or moderate inhibitors of the drug-metabolizing enzyme (CYP2D6) within 4 weeks prior to screening
• 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;
• 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;
• 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.);
• Pregnant or lactating women, or female participants with a positive pregnancy test at screening;
• 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;

Sponsors & Collaborators

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

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

RECRUITING

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug:Ammoxetine hydrochloride Enteric-coated Tablets Other: N/A

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: August 11, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

CN (1)