Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

NCT ID: NCT03456388

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2019-02-15

Brief 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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ammoxetine Hydrochloride Enteric-coated Tablets

There will be 7 ascending cohorts . Each cohort will be administered in different dose once for 7 days.

Group Type: EXPERIMENTAL

Ammoxetine Hydrochloride Enteric-coated Tablets

Intervention Type: DRUG

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. placebo enteric-coate tablets to mimic Ammoxetine Hydrochloride Enteric-coated tablets.

Group Type: ACTIVE_COMPARATOR

placebo enteric-coated tablets

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qi Shen

Role: PRINCIPAL_INVESTIGATOR

Sichuan huaxi hospital 1 ward.

Locations

Sichuan huaxi hospital 1 ward.

Chengdu, Sichuan, China

Countries

China

Other Identifiers

AMXT201701/PRO

Identifier Type: -

Identifier Source: org_study_id