NCT05129137

Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)

Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg) and Individual Nefopam Hydrochloride and Paracetamol Taken Alone or Concomitantly After Oral Single Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Unither Pharmaceuticals, France · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or concomitantly after oral single dose.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	nefopam hydrochloride 30mg X2	nefopam hydrochloride 30mg X2
DRUG	paracetamol 500 mg X2	paracetamol 500 mg X2
DRUG	Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2	Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2

Timeline

• Start date: 2021-11-29
• Primary completion: 2021-12-27
• Completion: 2021-12-27
• First posted: 2021-11-22
• Last updated: 2024-10-31
• Results posted: 2024-10-31

Locations

1 site across 1 country: India