Phase 1
Completed N=32
Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)
Healthy Volunteers
Source: ClinicalTrials.gov NCT05129137 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose — 101.808; 114.957; NA; 118.528 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose |
1206.310; 1275.371; NA; 1268.071; 71402.500; NA | — |
| SECONDARY Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose |
53400.117; 56726.962; 54559.464; 848700.451; 895791.865; 857425.472 | — |
| SECONDARY N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose |
671.457; 679.468; 692.628 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
1; 1; 0; 2 | — |
Eligibility Criteria
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,
Data sourced from ClinicalTrials.gov (NCT05129137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.