Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject
Phase 1
- Conditions
- Depression
- Interventions
- Drug: Ammoxetine Hydrochloride Enteric-coated TabletsDrug: placebo enteric-coated tablets
- Registration Number
- NCT03850834
- 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 healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ammoxetine Hydrochloride Enteric-coated Tablets Ammoxetine Hydrochloride Enteric-coated Tablets - Placebo Enteric-coated Tablets placebo enteric-coated tablets -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Event 15 days Incidence of Adverse Events that researchers determined clinical significance
Half life Period (t1/2) 11 days The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Area under the plasma concentration time curve (AUC) 11 days The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Maximum concentration (Cmax) 11 days The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
- Secondary Outcome Measures
Name Time Method