Sichuan huaxi hospital 1 ward.
Chengdu, Sichuan, 610000, China
NCT Number: NCT03456388
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.
Looking for future studies?
Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Chengdu, Sichuan, 610000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 8 days
Incidence of Adverse Events that researchers determined clinical significance
Time frame: 8 days
changes in blood concentration
Time frame: 8 days
the metabolite analysis in sample of plasma, urine and fecal.
Time frame: 8days
changes in urine concentration
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Industry
A Phase ⅠAscending Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese Healthy Subjects
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.
Published trials that share one or more normalized conditions with this study.
NCT06139016
Behavior, Behavioral Symptoms
New Haven, Connecticut, United States
View Trial DetailsNCT06942637
Adolescents, Anxiety
Bandung, West Java, Indonesia
View Trial DetailsNCT04276259
Behavior, Behavioral Symptoms
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT07737652
Anxiety, Anxiety Disorders
Tuscaloosa, Alabama, United States
View Trial Details