---
title: Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject
nct_id: NCT03850834
overall_status: UNKNOWN
phase: PHASE1
sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Depression
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03850834.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03850834"
ct_last_update_post_date: 2019-02-22
last_seen_at: "2026-05-12T06:35:41.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject

**Official Title:** A Multiple-dose Study to Evaluate the Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects

**NCT ID:** [NCT03850834](https://clinicaltrials.gov/study/NCT03850834)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- **Conditions:** Depression
- **Start Date:** 2019-03-10
- **Completion Date:** 2019-10-31
- **CT.gov Last Update:** 2019-02-22

## Brief Summary

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese healthy subjects

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Males and females age 18-45 years
* Body weight ≥ 45kg (female) or 50Kg (male), 18 ≤ BMI ≤ 26
* Vital signs, physical examinations and laboratory tests and other tests prove participants are healthy
* Sign the informed consent form voluntarily and cooperate voluntarily to complete the test

Exclusion Criteria:

* Allergens (allergic to 2 or more drugs, food or pollen)
* comorbid illness (mental illness, liver and kidney disease, gastrointestinal diseases, nervous system disease, or other systemic diseases)
* have Clinically significant abnormal screening laboratory values.
* Systolic pressure \> 140mmHg or diastolic \> 90 mmHg
* Postural hypotension (systolic blood pressure drop by 20mmHg or diastolic blood pressure drop by 10mmHg after standing position)
* The QTc period ≥ 450ms (male) or 470ms (female) or has a history of QTc extension
* Smoking or alcohol consumption (14 units per week in the previous 4 weeks : 1 unit = beer 285mL, or 25mL of spirits, or 150 mL of wine; Daily smoking ≥ 5) or abusing in past year of drug and other substance
* Have donated or lost blood 400 ml within 8 weeks prior to screening
* Participated in other clinical trials within 3 months prior to screening
* Intakes too much caffeinated beverage or food within 4 weeks prior to screening. such as: Coffee, tea, chocolate, cola, red bull (no more than 6 units per day). 1 unit of caffeine = 1 cup of coffee (177.4 mL) = 2 pots of cola (354.9 mL) = 1 cup of tea (354.9 mL) = 1/2 cup energy drink = 85g chocolate
* Have taken drugs that changed liver enzyme activity, such as dexamethasone, ketoconazole, rifampicin and omeprazole, were used within 4 weeks prior to screening
* Have taken prescription drugs and OTC (except for the occasional use of acetaminophen and nasal sprays), herbs vitamins or minerals within 4 weeks prior to screening. The interval from prior treatment to screening should be at least 5 half-lives metablism which subjected to the longer halflife
* Using any psychotropic drug or psychoactive substance
* Women were screened for positive blood pregnancy
* The subjects and their partners were not willing to take contraceptives during trial and six months after the study
* Have a donor plan recently
* Have participated in this trial
* The researchers believe that anyone who is unfit to participate in this test will be involved
```

## Arms

- **Ammoxetine Hydrochloride Enteric-coated Tablets** (EXPERIMENTAL)
- **Placebo Enteric-coated Tablets** (PLACEBO_COMPARATOR)

## Interventions

- **Ammoxetine Hydrochloride Enteric-coated Tablets** (DRUG) — There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested
- **placebo enteric-coated tablets** (DRUG) — There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested

## Primary Outcomes

- **Incidence of Treatment-Emergent Adverse Event** _(time frame: 15 days)_ — Incidence of Adverse Events that researchers determined clinical significance
- **Area under the plasma concentration time curve (AUC)** _(time frame: 11 days)_ — The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
- **Maximum concentration (Cmax)** _(time frame: 11 days)_ — The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
- **Half life Period (t1/2)** _(time frame: 11 days)_ — The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03850834.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03850834*  
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