Overview

Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

Status:
Completed
Trial end date:
2019-02-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Criteria
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