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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2021-12-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

An open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteers

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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nefopam hydrochloride 30mg X2

Intervention Type DRUG

paracetamol 500 mg X2

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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acetaminophen

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes