ARL/20/277: Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)
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 |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Inclusion Criteria:
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Male and non-pregnant female human subjects, age 18 - 45 years.
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Body Mass Index between 18.5-30 Kg / m2 .
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Subjects with normal findings .
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Willingness to follow the protocol requirements
Exclusion Criteria:
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Known history of hypersensitivity to Nefopam, Paracetamol or related drugs.
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Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
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Subjects with a history of convulsive disorders.
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Subject with a moderate or severe renal impairment
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History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
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Female subjects not confirming to using birth control measures,
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- UP-CLI-2019-001