Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

Depression Clinical Trial

Official title:

A Phase ⅠAscending Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456388
• Other study ID #: AMXT201701/PRO
• Status: Completed
• Phase: Phase 1
• Start date: October 30, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: August 2018
• 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 heathy subjects. Part of the participants will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will receive placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 15, 2019
• Est. primary completion date: July 11, 2018
• 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 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

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• Ammoxetine Hydrochloride Enteric-coated Tablets
There will be 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. 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 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. 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
China	Sichuan huaxi hospital 1 ward.	Chengdu	Si Chuan

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Incidence of Adverse Events that researchers determined clinical significance	8 days
Secondary	Pharmacokinetics of blood sample	changes in blood concentration	8 days
Secondary	Mass balance	the metabolite analysis in sample of plasma, urine and fecal.	8 days
Secondary	Pharmacokinetics of urine sample	changes in urine concentration	8days