A Phase 1 interventional study of Toludivenlafaxine hydrochloride sustained-release tablets in Major Depressive Disorder, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Shanghai Mental Health Center · Phase 1, Interventional, and Treatment
This study was a single-arm, non-randomized, open-label clinical study to assess dopamine transporter occupancy in the brain of healthy adults using 11C-CFT positron emission tomography (PET)
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 6 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of the following medications or treatments prior to dosing:
Use of any prescription medication within 28 days prior to dosing; Use of any over-the-counter medications, including health products, within 7 days prior to dosing; Receipt of any contrast agent or radiopharmaceutical within 48 hours prior to, or application of contrast agent within 24 hours after, administration of the trial drug;
80 mg/tablet, 2 tablets each time, once a day, for 4 days
Drug: Toludivenlafaxine hydrochloride sustained-release tablets
80 mg/tablet, 2 tablets each time, once a day, for 4 days, orally at 30 min after the start of meals, 200 mL water to take
Percentage of Dopamine Transporters Occupancy in the Basal Ganglia(Positron emission tomography with 11C-CFT was determine by SUVr of the Basal Ganglia DAT) in Human Brain by Toludivenlafaxine Hydrochloride Extended-Release Tablets
Time frame: from baseline to day 4
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Mental Health Center