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

Unither Pharmaceuticals, France32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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,

Locations (1)

Accutest Research Laboratories

Navi Mumbai, India

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: up to 48 hours post dose

Secondary Outcomes

Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose

Peak Plasma Concentration (Cmax) 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

Time frame: up to 48 hours post dose

Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single 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

Time frame: up to 48 hours post dose

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

Peak Plasma Concentration (Cmax) 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

Data from ClinicalTrials.gov

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