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

NCT05129137 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-10-31

Study results available
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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

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

Sponsors & Collaborators

  • Accutest Research Laboratories (I) Pvt. Ltd.

    collaborator INDUSTRY

  • Unither Pharmaceuticals, France

    lead INDUSTRY

Principal Investigators

  • Pramila Yadav, MS · Accutest Research Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2021-12-27
Completion
2021-12-27

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129137 on ClinicalTrials.gov