NCT03850834UnknownPhase 1
A Multiple-dose Study to Evaluate the Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 sites36 target enrollmentStarted: March 10, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 36
- Primary Endpoint
- Maximum concentration (Cmax)
Study Overview
Brief Summary
This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese healthy subjects
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Ammoxetine Hydrochloride Enteric-coated Tablets
Experimental
Intervention: Ammoxetine Hydrochloride Enteric-coated Tablets (Drug)
Placebo Enteric-coated Tablets
Placebo Comparator
Intervention: placebo enteric-coated tablets (Drug)
Outcomes
Primary Outcomes
Maximum concentration (Cmax)
Time Frame: 11 days
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Incidence of Treatment-Emergent Adverse Event
Time Frame: 15 days
Incidence of Adverse Events that researchers determined clinical significance
Half life Period (t1/2)
Time Frame: 11 days
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Area under the plasma concentration time curve (AUC)
Time Frame: 11 days
The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets
Secondary Outcomes
No secondary outcomes reported
Investigators
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