A Phase 1 interventional study of narfurine hydrochloride orally disintegrating tablets in Improvement of Pruritus in Hemodialysis Patients, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 1, Interventional, and Treatment
Main objective: To evaluate the pharmacokinetics of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
Secondary objective: To evaluate the safety profile of single and multiple oral administration of narfurine hydrochloride orally disintegrating tablets in Chinese healthy adult subjects.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 294 interventional studies indexed under Pruritus.
Browse Pruritus studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During the study session, 30 healthy subjects will be administered a single and multiple dose of narfurine hydrochloride orally disintegrating tablets 5 µg (2.5 µg/table) to evaluate the pharmacokinetic parameters and the safety profile.
Drug: narfurine hydrochloride orally disintegrating tablets
Subjects swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM on D1; swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM starting on D4. Dosing for 7 consecutive days (D10 last dose in the morning).
AUC AUC
Area Under the Plasma Concentration-time Curve
Time frame: Day1 to Day13
Cmax
Maximum Observed Plasma Concentration
Time frame: Day1 to Day13
Tmax
Time to Reach the Maximum Plasma Concentration
Time frame: Day1 to Day13
t1/2
Elimination half-life
Time frame: Day1 to Day13
Kel
Elimination rate constant
Time frame: Day1 to Day13
CL/F CL/F
Apparent clearance
Time frame: Day1 to Day13
Vd/F
Apparent distribution volume based on terminal elimination phase
Time frame: Day1 to Day13
MRT
Mean residence time
Time frame: Day1 to Day13
Css_max
Steady state peak concentration
Time frame: Day1 to Day13
Css_min
Steady state Valley concentration
Time frame: Day1 to Day13
Css_av
Steady state average concentration
Time frame: Day1 to Day13
DF
Volatility index
Time frame: Day1 to Day13
Safety and tolerance indicators
AE and SAE
Time frame: Day1 to Day13
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Zhejiang University