NCT05315479

Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Baudax Bio · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to \<17 years.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	N1539	Once daily

Timeline

• Start date: 2022-02-24
• Primary completion: 2022-07-07
• Completion: 2022-07-07
• First posted: 2022-04-07
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study