Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject

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

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

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Drug: Ammoxetine Hydrochloride Enteric-coated Tablets; Drug: placebo enteric-coated tablets

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ammoxetine Hydrochloride Enteric-coated Tablets	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_COMPARATOR: Placebo Enteric-coated Tablets	Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 10, 2019
• Primary Completion (ANTICIPATED): May 31, 2019
• Study Completion (ANTICIPATED): October 31, 2019

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (ACTUAL): February 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: AMXT201802/PRO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No