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

NCT05129137 | Completed Phase 1 Results

• 1 other identifier: UP-CLI-2019-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose

  Peak Plasma Concentration (Cmax) of nefopam hydrochloride and paracetamol after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours

  up to 48 hours post dose

• Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose

  Area under the plasma concentration versus time curve (AUC) of nefopam hydrochloride and paracetamol after single dose at different timepoints : Within 60 min before drug administration),0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours

  up to 48 hours post dose

Secondary Outcomes (5)

• Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose

  up to 48 hours post dose

• Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose

  up to 48 hours post dose

• N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose

  up to 48 hours post dose

• N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose

  up to 48 hours post dose

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 48 hours

Study Arms (4)

FDC nefopam hydrochloride 30mg / paracetamol 500mg

EXPERIMENTAL

Single dose: 2 tablets

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

nefopam hydrochloride 30mg

ACTIVE COMPARATOR

Single dose: 2 tablets

Drug: nefopam hydrochloride 30mg X2

paracetamol 500mg

ACTIVE COMPARATOR

Single dose: 2 tablets

Drug: paracetamol 500 mg X2

nefopam hydrochloride 30mg and paracetamol 500mg

ACTIVE COMPARATOR

Single dose: 2 tablets

Drug: nefopam hydrochloride 30mg X2; Drug: paracetamol 500 mg X2

Interventions

nefopam hydrochloride 30mg X2 DRUG

nefopam hydrochloride 30mg X2

nefopam hydrochloride 30mg; nefopam hydrochloride 30mg and paracetamol 500mg

paracetamol 500 mg X2 DRUG

paracetamol 500 mg X2

Also known as: acetaminophen

nefopam hydrochloride 30mg and paracetamol 500mg; paracetamol 500mg

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

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

FDC nefopam hydrochloride 30mg / paracetamol 500mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and non-pregnant female human subjects, age 18 - 45 years.
• Body Mass Index between 18.5-30 Kg / m2 .
• Subjects with normal findings .
• Willingness to follow the protocol requirements

You may not qualify if:

• Known history of hypersensitivity to Nefopam, Paracetamol or related drugs.
• Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
• Subjects with a history of convulsive disorders.
• Subject with a moderate or severe renal impairment
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
• Female subjects not confirming to using birth control measures,

Sponsors & Collaborators

• Unither Pharmaceuticals, France: lead
• Accutest Research Laboratories (I) Pvt. Ltd.: collaborator

Study Sites (1)

Accutest Research Laboratories

Navi Mumbai, 400709, India

Location

MeSH Terms

Interventions

Nefopam; Acetaminophen

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Non-Clinical and Clinical Project Manager
• Organization: Unither Pharmaceuticals

clinicaltrials@unither-pharma.com

+33 (0)1 44 63 51 78

Study Officials

• Pramila Yadav, MS

  Accutest Research Laboratories

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteers

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 22, 2021
• Study Start: November 29, 2021
• Primary Completion: December 27, 2021
• Study Completion: December 27, 2021
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)