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

Healthy Volunteers Clinical Trial

— ARL/20/277  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129137
• Other study ID #: UP-CLI-2019-001
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2021
• Est. completion date: December 27, 2021

Study information

• Verified date: February 2022
• Source: Unither Pharmaceuticals, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 27, 2021
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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,

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
India	Accutest Research Laboratories	Navi Mumbai

Sponsors (2)

Lead Sponsor	Collaborator
Unither Pharmaceuticals, France	Accutest Research Laboratories (I) Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	up to 48 hours post dose
Secondary	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	up to 48 hours post dose
Secondary	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	up to 48 hours post dose
Secondary	N-desmethyl-nefopam Pharmacokinetic profiles in each arms after single 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	up to 48 hours post dose
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Occurrence and severity of adverse events (serious and non-serious adverse events)	Up to 48 hours