ARL/20/277: Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)

Sponsor
Unither Pharmaceuticals, France (Industry)
Overall Status
Completed
CT.gov ID
NCT05129137
Collaborator
Accutest Research Laboratories (I) Pvt. Ltd. (Industry)
31
1
4
28
33.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: nefopam hydrochloride 30mg X2
  • Drug: paracetamol 500 mg X2
  • Drug: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
An open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteersAn open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteers
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official 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
Actual Study Start Date :
Nov 29, 2021
Actual Primary Completion Date :
Dec 27, 2021
Actual Study Completion Date :
Dec 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: FDC nefopam hydrochloride 30mg / paracetamol 500mg

Single dose: 2 tablets

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

Active Comparator: nefopam hydrochloride 30mg

Single dose: 2 tablets

Drug: nefopam hydrochloride 30mg X2
nefopam hydrochloride 30mg X2

Active Comparator: paracetamol 500mg

Single dose: 2 tablets

Drug: paracetamol 500 mg X2
paracetamol 500 mg X2
Other Names:
  • acetaminophen
  • Active Comparator: nefopam hydrochloride 30mg and paracetamol 500mg

    Single dose: 2 tablets

    Drug: nefopam hydrochloride 30mg X2
    nefopam hydrochloride 30mg X2

    Drug: paracetamol 500 mg X2
    paracetamol 500 mg X2
    Other Names:
  • acetaminophen
  • Outcome Measures

    Primary Outcome Measures

    1. Nefopam and Paracetamol Pharmacokinetic profiles in each arms after single dose [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 [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

    1. Paracetamol metabolites Pharmacokinetic profiles in each arms after single dose [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 [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 [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 [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] [Up to 48 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Accutest Research Laboratories Navi Mumbai India 400709

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Pramila Yadav, MS, Accutest Research Laboratories

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Unither Pharmaceuticals, France
    ClinicalTrials.gov Identifier:
    NCT05129137
    Other Study ID Numbers:
    • UP-CLI-2019-001
    First Posted:
    Nov 22, 2021
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 25, 2022