Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject

• Status: Unknown status
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• 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 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