Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject

Depression Clinical Trial

Official title:

A Multiple-dose Study to Evaluate the Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03850834
• Other study ID #: AMXT201802/PRO
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 10, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2019
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: October 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• Ammoxetine Hydrochloride Enteric-coated Tablets
There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested
• placebo enteric-coated tablets
There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Event	Incidence of Adverse Events that researchers determined clinical significance	15 days
Primary	Area under the plasma concentration time curve (AUC)	The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets	11 days
Primary	Maximum concentration (Cmax)	The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets	11 days
Primary	Half life Period (t1/2)	The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets	11 days