Skip to main content
OpenTrials
Completed

NCT Number: NCT05129137

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Accutest Research Laboratories

Navi Mumbai, 400709, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

nefopam hydrochloride 30mg X2

Drug

nefopam hydrochloride 30mg X2

paracetamol 500 mg X2

Drug

paracetamol 500 mg X2

Other names: acetaminophen

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

Drug

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

Primary outcomes

  1. Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose

    Time frame: up to 48 hours post 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

  2. Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose

    Time frame: 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 outcomes

  1. Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose

    Time frame: up to 48 hours post 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

  2. Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose

    Time frame: 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

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

    Time frame: up to 48 hours post 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

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

    Time frame: 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

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

    Time frame: Up to 48 hours

    Occurrence and severity of adverse events (serious and non-serious adverse events)

Sponsors and collaborators

Lead sponsor

Unither Pharmaceuticals, France

Industry

Collaborators

  • Accutest Research Laboratories (I) Pvt. Ltd.

Registry information

Official study title

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

Acronym: ARL/20/277

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2021
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.