Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

CSPC Pharmaceutical Group

Status and phase

Completed

Phase 1

Conditions

Depression

Treatments

Drug: Ammoxetine Hydrochloride Enteric-coated Tablets

Drug: placebo enteric-coated tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT03456388

AMXT201701/PRO

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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