CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
nefopam hydrochloride 30mg X2 +2 moredrug
Likely dose
nefopam hydrochloride 30mg X2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05129137
NCT05129137Phase 1Completed
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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

Unither Pharmaceuticals, France·interventional·Posted Nov 22, 2021·Updated Oct 31, 2024

In Brief

A Phase 1 clinical trial evaluating nefopam hydrochloride 30mg X2, paracetamol 500 mg X2, and 1 other intervention for Healthy Volunteers. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesIndia
CollaboratorsAccutest Research Laboratories (I) Pvt. Ltd.

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedNov 22, 2021
Enrollment StartNov 29, 2021
Primary CompletionDec 27, 2021
TodayJul 2, 2026
Enrollment to primary: 28 daysPosted 4.6 years ago

Interventions

nefopam hydrochloride 30mg X2drug

nefopam hydrochloride 30mg X2

paracetamol 500 mg X2drug

paracetamol 500 mg X2

Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2drug

Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2