Healthy VolunteersPhase 1ARL/20/277NCT05129137
Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)
A Phase 1 study testing nefopam hydrochloride 30mg X2, paracetamol 500 mg X2 and Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2 in people with Healthy Volunteers, run by Unither Pharmaceuticals, France at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- nefopam hydrochloride 30mg X2, paracetamol 500 mg X2 and Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 29 Nov 2021to 27 Dec 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- nefopam hydrochloride 30mg X2, paracetamol 500 mg X2, Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nefopam hydrochloride 30mg X2Drug
nefopam hydrochloride 30mg X2
paracetamol 500 mg X2Drug
Also called acetaminophen
paracetamol 500 mg X2
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2Drug
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
| Study group | Role | What they receive |
|---|---|---|
| FDC nefopam hydrochloride 30mg / paracetamol 500mg | Experimental | Single dose: 2 tablets Receives: Drug: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2 |
| nefopam hydrochloride 30mg | Active comparator | Single dose: 2 tablets Receives: Drug: nefopam hydrochloride 30mg X2 |
| paracetamol 500mg | Active comparator | Single dose: 2 tablets Receives: Drug: paracetamol 500 mg X2 |
| nefopam hydrochloride 30mg and paracetamol 500mg | Active comparator | Single dose: 2 tablets Receives: Drug: nefopam hydrochloride 30mg X2; Drug: paracetamol 500 mg X2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 48 hours post dose
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
Measured: up to 48 hours post dose
Secondary outcomes (5)
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
Measured: up to 48 hours post dose
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
Measured: up to 48 hours post dose
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
Measured: up to 48 hours post dose
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
Measured: up to 48 hours post dose
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence and severity of adverse events (serious and non-serious adverse events)
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start29 Nov 2021
- Primary completion27 Dec 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteers
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accutest Research Laboratories (I) Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Pramila Yadav, MS, Principal investigator, Accutest Research Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129137
- Sponsor's protocol ID
- UP-CLI-2019-001
- Acronym
- ARL/20/277
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2021
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05129137
- Acronym / sponsor ID
- ARL/20/277 / UP-CLI-2019-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Unither Pharmaceuticals, FranceIndustry (pharma, biotech, devices)
- Collaborators
- Accutest Research Laboratories (I) Pvt. Ltd.
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- An open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| FDC nefopam hydrochloride 30mg / paracetamol 500mg | Experimental | Drug: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2Single dose: 2 tablets |
| nefopam hydrochloride 30mg | Active comparator | Drug: nefopam hydrochloride 30mg X2Single dose: 2 tablets |
| paracetamol 500mg | Active comparator | Drug: paracetamol 500 mg X2Single dose: 2 tablets |
| nefopam hydrochloride 30mg and paracetamol 500mg | Active comparator | Drug: nefopam hydrochloride 30mg X2, Drug: paracetamol 500 mg X2Single dose: 2 tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nefopam hydrochloride 30mg X2nefopam hydrochloride 30mg X2 | Drug | nefopam hydrochloride 30mg, nefopam hydrochloride 30mg and paracetamol 500mg |
| paracetamol 500 mg X2Also: acetaminophenparacetamol 500 mg X2 | Drug | nefopam hydrochloride 30mg and paracetamol 500mg, paracetamol 500mg |
| Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2 | Drug | FDC nefopam hydrochloride 30mg / paracetamol 500mg |
Primary outcome
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
Time frame: 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
Time frame: 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
5 secondary outcomes
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose
Time frame: up to 48 hours post dose
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose
Time frame: up to 48 hours post dose
N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose
Time frame: up to 48 hours post dose
N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose
Time frame: up to 48 hours post dose
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pramila Yadav, MS principal investigator
Accutest Research Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nefopam hydrochloride 30mg X2, paracetamol 500 mg X2 and Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2 in people with Healthy Volunteers, run by Unither Pharmaceuticals, France at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose (time frame: up to 48 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.