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A Pharmacokinetics and Safety Study of Narfurine Hydrochloride Orally Disintegrating Tablets

NCT04420234 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-09-09

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Shenyang Sunshine Pharmaceutical Co., LTD.

    collaborator INDUSTRY

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • jian liu, master · The First Affiliated Hospital,ZheJiang Univercity

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2020-07-28
Completion
2020-12-31

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420234 on ClinicalTrials.gov