Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibuprofen arginine granules · 1 trial · 1 indication
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.
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 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) 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) 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 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.
| Arm | Type | Description |
|---|---|---|
| Ibuprofen arginine granules 400 mg | EXPERIMENTAL | Participants will be randomly assigned as per cross-over design to receive one sachet of Ibuprofen arginine granules 400 mg (test product) on day 1 of period 1 and will receive one sachet of Ibuprofen arginine granules 400 mg (Spedifen) (reference product) on day 1 of period 2 with at least 2 days washout period. Participants will be instructed to consume the product orally by dissolving it in 240 mL of warm water. |
| Ibuprofen arginine granules 400 mg (Spedifen) | ACTIVE_COMPARATOR | Participants will be randomly assigned as per cross-over design to receive one sachet of Ibuprofen arginine granules 400 mg (Spedifen) (reference product) on day 1 of period 1 and will receive one sachet of Ibuprofen arginine granules 400 mg (test product) on day 1 of period 2 with at least 2 days washout period. Participants will be instructed to consume the product orally by dissolving it in 240 mL of warm water. |
| Name | Type | Description |
|---|---|---|
| Ibuprofen arginine granules 400 mg | DRUG | Experimental- Ibuprofen arginine granules 400 mg, one sachet administration containing 400 mg ibuprofen granules. |
| Ibuprofen arginine granules 400 mg (Spedifen) | DRUG | Marketed drug- Ibuprofen arginine granules 400 mg (Spedifen), one sachet administration containing 400 mg ibuprofen granules. |
Inclusion Criteria: * Participants provision of a signed and dated informed consent and/or assent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Participants who is willing and able to comply with scheduled visi...
Ibuprofen arginine granules is an investigational small molecule formulation of ibuprofen combined with arginine, developed by Haleon plc (ticker HLN). It is being studied for pain. The drug is in Phase 1 clinical development and is not approved; the only listed trial is a completed bioequivalence study in healthy adults.
Ibuprofen arginine granules is being developed for the treatment of pain. It is an investigational product in Phase 1 development, so it is not approved for any use. The single registered trial enrolled healthy adult volunteers in China to compare two 400 mg formulations rather than to test pain relief.
Ibuprofen arginine granules targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these enzymes. The arginine component is combined with ibuprofen in a granule formulation, and the drug is a small molecule in Phase 1 development for pain.
Ibuprofen arginine granules is developed by Haleon plc, which trades under the ticker HLN. Haleon is the company listed as the developer of this investigational pain asset, which is currently in Phase 1 clinical development.
Ibuprofen arginine granules is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulator based on the available information. One Phase 1 trial has been completed, and no trials are currently active.
Ibuprofen arginine granules has been studied in one completed Phase 1 trial, NCT05737069. That trial was a bioequivalence study of two ibuprofen arginine granules 400 mg formulations under fasting and fed conditions in Chinese healthy adult subjects. It enrolled 84 participants, was randomized and active controlled, and took place in China.