Adults 18 to 50, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Plasma Concentration Time Curve From Time Zero to Last Observed Concentration at Time t (AUC[0-t]) for Ibuprofen in Fasted ConditionsPrimary· Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Area Under the Plasma Concentration Time Curve From Time Zero to Time Infinity (AUC [0-inf]) for Ibuprofen in Fasted ConditionsPrimary· Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC(0-inf) = AUC(0-t) +Ct/λz where Ct was the plasma concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of AUC(0-inf). PK parameters were determined by non-compartmental analysis.
Observed Maximum Plasma Concentration (Cmax) for Ibuprofen in Fasted ConditionsPrimary· Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
AUC(0-t) for Ibuprofen in Fed ConditionsPrimary· Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). PK parameters were determined by non-compartmental analysis.
AUC (0-inf) for Ibuprofen in Fed ConditionsPrimary· Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC(0-inf) = AUC(0-t) +Ct/λz where Ct was the plasma concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of AUC(0-inf). PK parameters were determined by non-compartmental analysis.
Cmax for Ibuprofen in Fed ConditionsPrimary· Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
Time to Reach Maximum Plasma Concentration (Tmax) of Ibuprofen in Fasted ConditionsSecondary· Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Blood samples were collected at indicated timepoints for the analysis of Tmax. PK parameters were determined by non-compartmental analysis.
Elimination Half-life (t1/2) of Ibuprofen in Fasted ConditionsSecondary· Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
t1/2 was defined as elimination half-life calculated as t1/2 = ln (2)/λz where λz was terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Terminal Elimination Rate Constant (λz) of Ibuprofen in Fasted ConditionsSecondary· Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
λz was defined as terminal elimination rate constant estimated by log-linear regression of the terminal part of the plasma concentration versus time curve. Blood samples were collected at indicated timepoints for the analysis of λz. PK parameters were determined by non-compartmental analysis.
Percentage of Extrapolated Area of AUC(0-inf) (%AUCex) of Ibuprofen in Fasted ConditionsSecondary· Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
%AUCex was calculated as %AUCex = (1- AUC\[0-t\] /AUC\[0-inf\])\*100%. Blood samples were collected at indicated timepoints for the analysis of %AUCex. PK parameters were determined by non-compartmental analysis.
t1/2 of Ibuprofen in Fed ConditionsSecondary· Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
t1/2 was defined as elimination half-life calculated as t1/2 = ln (2)/λz where λz was terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Time frame: From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants. The secondary purpose of this study is to assess the pharmacokinetic and safety profile of the test and reference preparations.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by HALEON
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05737069.