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

Unither Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129137

UP-CLI-2019-001

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

FDC nefopam hydrochloride 30mg / paracetamol 500mg

Experimental group

Description:

Single dose: 2 tablets

Treatment:

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

nefopam hydrochloride 30mg

Active Comparator group

Description:

Single dose: 2 tablets

Treatment:

Drug: nefopam hydrochloride 30mg X2

paracetamol 500mg

Active Comparator group

Description:

Single dose: 2 tablets

Treatment:

Drug: paracetamol 500 mg X2

nefopam hydrochloride 30mg and paracetamol 500mg

Active Comparator group

Description:

Single dose: 2 tablets

Treatment:

Drug: paracetamol 500 mg X2

Drug: nefopam hydrochloride 30mg X2