Pharmacokinetic Study of Single and Multiple Intravenous Administration of Nalbuphine Hydrochloride Injection in Healthy Chinese Volunteers
NCT06902103 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2025-03-30
Summary
Objective:To evaluate the pharmacokinetic characteristics and safety of single and multiple intravenous injections of nalbuphine hydrochloride injection in healthy subjects.
Conditions
Interventions
- DRUG
-
Nabufine Hydrochloride Injection
PartA: Nabufine Hydrochloride Injection are administered Intravenous injection single dose
- DRUG
-
Nabufine Hydrochloride Injection
PartB: Nabufine Hydrochloride Injection are administered Intravenous injection multi dose
Sponsors & Collaborators
-
Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-20
- Primary Completion
- 2023-12-26
- Completion
- 2024-01-18
Countries
- China
Study Locations
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