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| Name | Class |
|---|---|
| Accutest Research Laboratories (I) Pvt. Ltd. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDC nefopam hydrochloride 30mg / paracetamol 500mg | Experimental | Single dose: 2 tablets |
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| nefopam hydrochloride 30mg | Active Comparator | Single dose: 2 tablets |
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| paracetamol 500mg | Active Comparator | Single dose: 2 tablets |
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| nefopam hydrochloride 30mg and paracetamol 500mg | Active Comparator | Single dose: 2 tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nefopam hydrochloride 30mg X2 | Drug | nefopam hydrochloride 30mg X2 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | up to 48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 48 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pramila Yadav, MS | Accutest Research Laboratories | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accutest Research Laboratories | Navi Mumbai | 400709 | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | FDC Nefopam HCl (NEF) 30mg / APAP 500mg Then NEF 30mg + APAP 500mg Then NEF 30mg Then APAP 500mg | Participant first received 2 tablets of Investigational Medicinal Product (IMP) 08P1737F0 (Fixed Drug combination) nefopam Hydrochloride (NEF) 30mg / paracetamol (APAP) 500mg) in a fasting state. After a wash-out of 1 week, they received 2 tablets of nefopam Hydrochloride 30mg (Acupan(r)) and 2 tablets of paracetamol (Panadol(r)) 500 mg in a fasting state. After a wash-out of 1 week, they received 2 tablets of nefopam Hydrochloride 30mg (Acupan(r)) in a fasting state. After a wash-out of 1 week, they received 2 tablets of paracetamol (Panadol(r)) 500mg in a fasting state. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2021 |
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An open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteers
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| paracetamol 500 mg X2 | Drug | paracetamol 500 mg X2 |
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| Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2 | Drug | Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2 |
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| 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 | 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 | 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 | 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) | Up to 48 hours |
| FG001 | NEF 30mg + APAP 500mg Then NEF 30mg Then APAP 500mg Then FDC Nefopam HCl (NEF) 30mg / APAP 500mg | Participant first received 2 tablets of nefopam Hydrochloride 30mg (Acupan(r)) and 2 tablets of paracetamol (Panadol(r)) 500mg in a fasting state. After a wash-out of 1 week, they received 2 tablets of nefopam Hydrochloride 30mg (Acupan(r)) in a fasting state. After a wash-out of 1 week, they received 2 tablets of paracetamol (Panadol(r)) 500mg in a fasting state. After a wash-out of 1 week, they received 2 tablets of IMP 08P1737F0 (FDC nefopam Hydrochloride 30mg / paracetamol 500mg) in a fasting state. |
| FG002 | NEF 30mg Then APAP 500mg Then FDC Nefopam HCl (NEF) 30mg Then NEF 30mg + APAP 500mg | Participant first received 2 tablets of nefopam Hydrochloride 30mg (Acupan(r)) in a fasting state. After a wash-out of 1 week, they received 2 tablets of paracetamol (Panadol(r)) 500mg in a fasting state. After a wash-out of 1 week, they received 2 tablets of IMP 08P1737F0 (FDC nefopam Hydrochloride 30mg / paracetamol 500mg) in a fasting state. After a wash-out of 1 week, they received 2 tablets of nefopam Hydrochloride 30mg (Acupan(r)) and 2 tablets of paracetamol (Panadol(r)) 500mg in a fasting state. |
| FG003 | APAP 500mg Then FDC Nefopam HCl (NEF) 30mg / APAP 500mg Then NEF 30mg + APAP 500mg Then NEF 30mg | Participant first received 2 tablets of paracetamol (Panadol(r)) 500mg in a fasting state. After a wash-out of 1 week, they received 2 tablets of IMP 08P1737F0 (FDC nefopam Hydrochloride 30mg / paracetamol 500mg) in a fasting state. After a wash-out of 1 week, they received 2 tablets of nefopam Hydrochloride 30mg (Acupan(r)) and 2 tablets of paracetamol (Panadol(r)) 500mg in a fasting state. After a wash-out of 1 week, they received 2 tablets nefopam Hydrochloride 30mg (Acupan(r)) in a fasting state. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Period |
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| Third Period |
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| Forth Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants has receivent every interventions |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Least Squares Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | ng/mL | up to 48 hours post dose |
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| Primary | 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 | Posted | Mean | Standard Deviation | ng*hr/mM | up to 48 hours post dose |
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| Secondary | 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 | Posted | Mean | Standard Deviation | ng/mL | up to 48 hours post dose |
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| Secondary | 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 | Posted | Mean | Standard Deviation | ng*hr/mL | up to 48 hours post dose |
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| Secondary | 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 | Posted | Mean | Standard Deviation | ng/mL | up to 48 hours post dose |
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| Secondary | 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 | Posted | Mean | Standard Deviation | ng*hr/mL | up to 48 hours post dose |
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| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Occurrence and severity of adverse events (serious and non-serious adverse events) | Posted | Number | event | Up to 48 hours |
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During the full duration of study (1 month)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg | Single dose: 2 tablets Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2 | 0 | 32 | 0 | 32 | 1 | 32 |
| EG001 | Nefopam Hydrochloride 30mg | Single dose: 2 tablets nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2 | 0 | 32 | 0 | 32 | 1 | 32 |
| EG002 | Paracetamol 500mg | Single dose: 2 tablets paracetamol 500 mg X2: paracetamol 500 mg X2 | 0 | 32 | 0 | 32 | 0 | 32 |
| EG003 | Nefopam Hydrochloride 30mg and Paracetamol 500mg | Single dose: 2 tablets nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2 paracetamol 500 mg X2: paracetamol 500 mg X2 | 0 | 32 | 0 | 32 | 1 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Giddiness | Nervous system disorders | MedDRA | Systematic Assessment |
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The CRO (ACCUTEST) shall not make any publication or communication, written or oral, in connection with the Study and the results of the Study, whether partial or final, without the prior written consent of the sponsor (UNITHER PHARMACEUTICALS) during, and following termination or expiration of this Clinical study Service Agreement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Non-Clinical and Clinical Project Manager | Unither Pharmaceuticals | +33 (0)1 44 63 51 78 | clinicaltrials@unither-pharma.com |
| Feb 28, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009340 | Nefopam |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010079 | Oxazocines |
| D001392 | Azocines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Cmax Paracetamol |
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