Trial Outcomes & Findings for A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult Subjects (NCT NCT05022810)
NCT ID: NCT05022810
Last Updated: 2024-02-20
Results Overview
Blood samples were collected at the indicated time points for the analysis of AUC (0-tlast). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis.
COMPLETED
PHASE1
61 participants
Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.
2024-02-20
Participant Flow
The study was conducted at single center in Czech Republic.
A total of 61 participants were enrolled into the study, of which 21 were screen failures, 5 were not assigned to any treatment and 35 were randomized to the study treatment. All the randomized participants completed the study.
Participant milestones
| Measure |
Test Drug/Reference Drug
Participants received new paracetamol suspension (Test drug) orally as a single 42 milliliter (mL) (1 gram \[g\] paracetamol) dose in treatment period 1. In treatment period 2, participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose. There was a washout period of 3 days between two treatment periods.
|
Reference Drug/Test Drug
Participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1. In treatment period 2, participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose. There was a washout period of 3 days between two treatment periods.
|
|---|---|---|
|
Period 1 (2 Days)
STARTED
|
18
|
17
|
|
Period 1 (2 Days)
COMPLETED
|
18
|
17
|
|
Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (3 Days)
STARTED
|
18
|
17
|
|
Washout Period (3 Days)
COMPLETED
|
18
|
17
|
|
Washout Period (3 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (2 Days)
STARTED
|
18
|
17
|
|
Period 2 (2 Days)
COMPLETED
|
18
|
17
|
|
Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Test Drug/Reference Drug
n=18 Participants
Participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1. In treatment period 2, participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose. There was a washout period of 3 days between two treatment periods.
|
Reference Drug/Test Drug
n=17 Participants
Participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1. In treatment period 2, participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose. There was a washout period of 3 days between two treatment periods.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.7 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
30.6 Years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
30.1 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.Population: PK Population - Comprised of participants in the 'Safety' population who complete the two periods and who have no major protocol deviations concerning PK.
Blood samples were collected at the indicated time points for the analysis of AUC (0-tlast). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Test Drug
n=35 Participants
Participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
Reference Drug
n=35 Participants
Participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
|---|---|---|
|
The Area Under the Plasma Concentration [AUC] Versus Time Curve Calculated From Time Zero to the Last Measurable Sampling Time Point (Tlast) (AUC [0-tlast])
|
47.18 microgram*hour/mL
Standard Deviation 9.3702
|
48.12 microgram*hour/mL
Standard Deviation 10.749
|
PRIMARY outcome
Timeframe: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.Population: PK Population.
Blood samples were collected at the indicated time points for for the analysis of tmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Test Drug
n=35 Participants
Participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
Reference Drug
n=35 Participants
Participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
|---|---|---|
|
The Time of the Maximum Observed Post-dose Concentration (Tmax)
|
1 hour
Interval 0.33 to 4.0
|
1 hour
Interval 0.5 to 2.0
|
PRIMARY outcome
Timeframe: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.Population: PK Population.
Blood samples were collected at the indicated time points for for the analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Test Drug
n=35 Participants
Participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
Reference Drug
n=35 Participants
Participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
|---|---|---|
|
The Maximum Observed Post-dose Concentration (Cmax)
|
11.63 microgram/mL
Standard Deviation 2.2598
|
11.59 microgram/mL
Standard Deviation 2.4865
|
SECONDARY outcome
Timeframe: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.Population: PK Population.
AUC (0-inf) = AUC (0-tlast) + Clast/ λz, where Clast is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Blood samples were collected at the indicated time points for for the analysis of AUC (0-inf). PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Test Drug
n=35 Participants
Participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
Reference Drug
n=35 Participants
Participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)]
|
49.14 microgram*hour/mL
Standard Deviation 9.6926
|
50.18 microgram*hour/mL
Standard Deviation 11.312
|
SECONDARY outcome
Timeframe: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post dose.Population: PK Population.
%AUCex = (1- \[AUC0-tlast/AUC0-inf\]\*100). Blood samples were collected at the indicated time points for for the analysis of %AUCex. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Test Drug
n=35 Participants
Participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
Reference Drug
n=35 Participants
Participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
|---|---|---|
|
Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex)
|
3.981 Percentage of AUC
Standard Deviation 1.5695
|
4.056 Percentage of AUC
Standard Deviation 1.5082
|
SECONDARY outcome
Timeframe: Pre-dose (-1 hour) and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.33, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours Post Dose.Population: PK Population.
λz is computed as the slope of the regression line of ln (concentration) verses time. Blood samples were collected at the indicated time points for for the analysis of λz. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Test Drug
n=35 Participants
Participants received new paracetamol suspension (Test drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
Reference Drug
n=35 Participants
Participants received marketed paracetamol suspension (Reference drug) orally as a single 42 mL (1 g paracetamol) dose in treatment period 1 and in treatment period 2.
|
|---|---|---|
|
Terminal Elimination Rate Constant (λz)
|
0.2061 1/hour
Standard Deviation 0.06784
|
0.2059 1/hour
Standard Deviation 0.06396
|
Adverse Events
Test Drug
Reference Drug
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER