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Completed

NCT Number: NCT03456388

Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sichuan huaxi hospital 1 ward.

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ammoxetine hydrochloride enteric-coated tablets

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

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.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 8 days

    Incidence of Adverse Events that researchers determined clinical significance

Secondary outcomes

  1. Pharmacokinetics of blood sample

    Time frame: 8 days

    changes in blood concentration

  2. Mass balance

    Time frame: 8 days

    the metabolite analysis in sample of plasma, urine and fecal.

  3. Pharmacokinetics of urine sample

    Time frame: 8days

    changes in urine concentration

Sponsors and collaborators

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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