Trial Outcomes & Findings for Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg) (NCT NCT05129137)
NCT ID: NCT05129137
Last Updated: 2024-10-31
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
up to 48 hours post dose
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
First Period
STARTED
|
8
|
8
|
8
|
8
|
|
First Period
COMPLETED
|
8
|
8
|
7
|
8
|
|
First Period
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Second Period
STARTED
|
8
|
8
|
7
|
8
|
|
Second Period
COMPLETED
|
7
|
8
|
7
|
7
|
|
Second Period
NOT COMPLETED
|
1
|
0
|
0
|
1
|
|
Third Period
STARTED
|
7
|
8
|
7
|
7
|
|
Third Period
COMPLETED
|
7
|
8
|
7
|
6
|
|
Third Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Forth Period
STARTED
|
7
|
8
|
7
|
6
|
|
Forth Period
COMPLETED
|
7
|
7
|
6
|
6
|
|
Forth Period
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Second Period
Adverse Event
|
1
|
0
|
0
|
0
|
|
Second Period
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Third Period
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Forth Period
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Forth Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=32 Participants
All study participants has receivent every interventions
|
|---|---|
|
Age, Continuous
|
32.97 years
STANDARD_DEVIATION 6.18 • n=32 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=32 Participants
|
|
Region of Enrollment
India
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: up to 48 hours post dosePeak 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
Outcome measures
| Measure |
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
|
Nefopam Hydrochloride 30mg
n=26 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
|
Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
paracetamol 500 mg X2: paracetamol 500 mg X2
|
Nefopam Hydrochloride 30mg and Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
paracetamol 500 mg X2: paracetamol 500 mg X2
|
|---|---|---|---|---|
|
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
Cmax Nefopam
|
101.808 ng/mL
Standard Deviation 38.283
|
114.957 ng/mL
Standard Deviation 40.071
|
NA ng/mL
Standard Deviation NA
Not applicable as nefopam is not taken in this arm
|
118.528 ng/mL
Standard Deviation 47.616
|
|
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
Cmax Paracetamol
|
13136.299 ng/mL
Standard Deviation 4292.658
|
NA ng/mL
Standard Deviation NA
Not applicable as paracetamol is not taken in this arm
|
21051.399 ng/mL
Standard Deviation 8155.946
|
17596.380 ng/mL
Standard Deviation 6431.919
|
PRIMARY outcome
Timeframe: up to 48 hours post doseArea 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
Outcome measures
| Measure |
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
|
Nefopam Hydrochloride 30mg
n=26 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
|
Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
paracetamol 500 mg X2: paracetamol 500 mg X2
|
Nefopam Hydrochloride 30mg and Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
paracetamol 500 mg X2: paracetamol 500 mg X2
|
|---|---|---|---|---|
|
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
AUC Nefopam
|
1206.310 ng*hr/mM
Standard Deviation 541.682
|
1275.371 ng*hr/mM
Standard Deviation 511.415
|
NA ng*hr/mM
Standard Deviation NA
Not applicable as nefopam is not taken in this arm
|
1268.071 ng*hr/mM
Standard Deviation 527.581
|
|
Nefopam and Paracetamol Pharmacokinetic Profiles in Each Arms After Single Dose
AUC Paracetamol
|
71402.500 ng*hr/mM
Standard Deviation 21114.375
|
NA ng*hr/mM
Standard Deviation NA
Not applicable as paracetamol is not taken in this arm
|
81877.185 ng*hr/mM
Standard Deviation 24007.993
|
78454.622 ng*hr/mM
Standard Deviation 23857.199
|
SECONDARY outcome
Timeframe: up to 48 hours post dosePeak 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
Outcome measures
| Measure |
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
|
Nefopam Hydrochloride 30mg
n=26 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
|
Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
paracetamol 500 mg X2: paracetamol 500 mg X2
|
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
|
|---|---|---|---|---|
|
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose
Cmax Paracetamol Sulfate
|
6696.526 ng/mL
Standard Deviation 1498.384
|
7110.342 ng/mL
Standard Deviation 1664.241
|
7064.836 ng/mL
Standard Deviation 1746.416
|
—
|
|
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose
Cmax Paracetamol Glucuronide
|
104919.677 ng/mL
Standard Deviation 34090.920
|
111556.414 ng/mL
Standard Deviation 38095.339
|
108171.336 ng/mL
Standard Deviation 37716.515
|
—
|
SECONDARY outcome
Timeframe: up to 48 hours post doseArea 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
Outcome measures
| Measure |
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
|
Nefopam Hydrochloride 30mg
n=26 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
|
Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
paracetamol 500 mg X2: paracetamol 500 mg X2
|
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
|
|---|---|---|---|---|
|
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose
AUC Paracetamol Sulfate
|
53400.117 ng*hr/mL
Standard Deviation 15051.893
|
56726.962 ng*hr/mL
Standard Deviation 16795.844
|
54559.464 ng*hr/mL
Standard Deviation 16443.774
|
—
|
|
Paracetamol Metabolites Pharmacokinetic Profiles in Each Arms After Single Dose
AUC Paracetamol Glucuronide
|
848700.451 ng*hr/mL
Standard Deviation 200394.870
|
895791.865 ng*hr/mL
Standard Deviation 237880.738
|
857425.472 ng*hr/mL
Standard Deviation 209544.721
|
—
|
SECONDARY outcome
Timeframe: up to 48 hours post dosePeak 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
Outcome measures
| Measure |
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
|
Nefopam Hydrochloride 30mg
n=26 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
|
Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
paracetamol 500 mg X2: paracetamol 500 mg X2
|
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
|
|---|---|---|---|---|
|
N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose
|
31.740 ng/mL
Standard Deviation 13.996
|
31.402 ng/mL
Standard Deviation 13.710
|
32.279 ng/mL
Standard Deviation 14.097
|
—
|
SECONDARY outcome
Timeframe: up to 48 hours post doseArea 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
Outcome measures
| Measure |
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
|
Nefopam Hydrochloride 30mg
n=26 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
|
Paracetamol 500mg
n=26 Participants
Single dose: 2 tablets
paracetamol 500 mg X2: paracetamol 500 mg X2
|
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
|
|---|---|---|---|---|
|
N-desmethyl-nefopam Pharmacokinetic Profiles in Each Arms After Single Dose
|
671.457 ng*hr/mL
Standard Deviation 228.793
|
679.468 ng*hr/mL
Standard Deviation 239.053
|
692.628 ng*hr/mL
Standard Deviation 239.316
|
—
|
SECONDARY outcome
Timeframe: Up to 48 hoursOccurrence and severity of adverse events (serious and non-serious adverse events)
Outcome measures
| Measure |
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
n=32 Participants
Single dose: 2 tablets
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
|
Nefopam Hydrochloride 30mg
n=32 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
|
Paracetamol 500mg
n=32 Participants
Single dose: 2 tablets
paracetamol 500 mg X2: paracetamol 500 mg X2
|
Nefopam Hydrochloride 30mg and Paracetamol 500mg
n=32 Participants
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
paracetamol 500 mg X2: paracetamol 500 mg X2
|
|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
|
1 event
|
1 event
|
0 event
|
2 event
|
Adverse Events
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nefopam Hydrochloride 30mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Paracetamol 500mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nefopam Hydrochloride 30mg and Paracetamol 500mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FDC Nefopam Hydrochloride 30mg / Paracetamol 500mg
n=32 participants at risk
Single dose: 2 tablets
Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
|
Nefopam Hydrochloride 30mg
n=32 participants at risk
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
|
Paracetamol 500mg
n=32 participants at risk
Single dose: 2 tablets
paracetamol 500 mg X2: paracetamol 500 mg X2
|
Nefopam Hydrochloride 30mg and Paracetamol 500mg
n=32 participants at risk
Single dose: 2 tablets
nefopam hydrochloride 30mg X2: nefopam hydrochloride 30mg X2
paracetamol 500 mg X2: paracetamol 500 mg X2
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • During the full duration of study (1 month)
|
3.1%
1/32 • Number of events 1 • During the full duration of study (1 month)
|
0.00%
0/32 • During the full duration of study (1 month)
|
3.1%
1/32 • Number of events 1 • During the full duration of study (1 month)
|
|
Nervous system disorders
Giddiness
|
0.00%
0/32 • During the full duration of study (1 month)
|
0.00%
0/32 • During the full duration of study (1 month)
|
0.00%
0/32 • During the full duration of study (1 month)
|
3.1%
1/32 • Number of events 1 • During the full duration of study (1 month)
|
Additional Information
Non-Clinical and Clinical Project Manager
Unither Pharmaceuticals
Phone: +33 (0)1 44 63 51 78
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER