NCT03311022

Bioequivalence Study of Nefopam Hydrochloride 30mg Tablets vs Acupan® 30mg Tablets in Healthy Subjects

A Randomised, Open-label, Single Dose, Crossover Study Investigating the Bioequivalence of Nefopam Hydrochloride 30mg Tablets With Acupan® 30mg Tablets in Healthy Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Galen Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the bioavailability of Nefopam Hydrochloride 30mg Tablets (test product) and Acupan® 30mg Tablets (reference product).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nefopam Hydrochloride 30mg Tablets
DRUG	Acupan® 30mg Tablets

Timeline

• Start date: 2015-11-06
• Primary completion: 2015-12-21
• Completion: 2015-12-21
• First posted: 2017-10-16
• Last updated: 2017-10-16

Locations

1 site across 1 country: United Kingdom