Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subject

NCT03850834 | Unknown Phase 1

• 1 other identifier: AMXT201802/PRO
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Ammoxetine Hydrochloride Enteric-coated Tablets

EXPERIMENTAL

Drug: Ammoxetine Hydrochloride Enteric-coated Tablets

Placebo Enteric-coated Tablets

PLACEBO COMPARATOR

Drug: placebo enteric-coated tablets

Interventions

Ammoxetine Hydrochloride Enteric-coated Tablets DRUG

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

Ammoxetine Hydrochloride Enteric-coated Tablets

placebo enteric-coated tablets DRUG

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: March 10, 2019
• Primary Completion: May 31, 2019
• Study Completion: October 31, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02