NCT04420234

A Pharmacokinetics and Safety Study of Narfurine Hydrochloride Orally Disintegrating Tablets

A Single-center Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Single and Multiple Oral Administration of Narfurine Hydrochloride Orally Disintegrating Tablets in Chinese Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Improvement of Pruritus in Hemodialysis Patients

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-06-09
• Primary completion: 2020-07-28
• Completion: 2020-12-01
• First posted: 2020-06-09
• Last updated: 2020-09-09

Locations

1 site across 1 country: China