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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: nefopam hydrochloride 30mg X2; Drug: paracetamol 500 mg X2

• Registration Number: NCT05129137
• Lead Sponsor: Unither Pharmaceuticals, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Study Start: 2021-11-29
• Primary Completion: 2021-12-27
• Study Completion: 2021-12-27
• Results First Submitted: 2024-02-28
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Results First Posted: 2024-10-31
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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

Exclusion Criteria

• 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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nefopam hydrochloride 30mg and paracetamol 500mg	nefopam hydrochloride 30mg X2	Single dose: 2 tablets
nefopam hydrochloride 30mg	nefopam hydrochloride 30mg X2	Single dose: 2 tablets
paracetamol 500mg	paracetamol 500 mg X2	Single dose: 2 tablets
nefopam hydrochloride 30mg and paracetamol 500mg	paracetamol 500 mg X2	Single dose: 2 tablets

Primary Outcome Measures

Name	Time	Method
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose	up to 48 hours post 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

Secondary Outcome Measures

Name	Time	Method
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose	up to 48 hours post dose	Area under the plasma concentration versus time curve (AUC) of main paracetamol metabolites (Sulfate and Glucuronide) 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
N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose	up to 48 hours post dose	Area under the plasma concentration versus time curve (AUC) of N-desmethyl-nefopam 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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 48 hours	Occurrence and severity of adverse events (serious and non-serious adverse events)

Trial Locations

Locations (1)

Accutest Research Laboratories; 🇮🇳 Navi Mumbai, India