Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: Ammoxetine Hydrochloride Enteric-coated Tablets; Drug: placebo enteric-coated tablets

• Registration Number: NCT03456388
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary

This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese heathy subjects. Part of the participants will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will receive placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-09
• Study Start: 2017-10-30
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-07
• Primary Completion: 2018-07-11
• Status Verified: 2018-08
• Study Completion: 2019-02-15
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 blood > 400 ml within 8 weeks prior to screening
• Participated in other clinical trials within 3 months prior to screening
• Intaked 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 half-life
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ammoxetine Hydrochloride Enteric-coated Tablets	Ammoxetine Hydrochloride Enteric-coated Tablets	There will be 7 ascending cohorts . Each cohort will be administered in different dose once for 7 days.
Placebo Enteric-coated Tablets	placebo enteric-coated tablets	There will be 7 ascending cohorts. placebo enteric-coate tablets to mimic Ammoxetine Hydrochloride Enteric-coated tablets.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	8 days	Incidence of Adverse Events that researchers determined clinical significance

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of blood sample	8 days	changes in blood concentration
Mass balance	8 days	the metabolite analysis in sample of plasma, urine and fecal.
Pharmacokinetics of urine sample	8days	changes in urine concentration

Trial Locations

Locations (1)

Sichuan huaxi hospital 1 ward.; 🇨🇳 Chengdu, Si Chuan, China