Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Advil PM Liqui-Gels Minis · 1 trial · 1 indication
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen obtained without interpolation. Blood samples were collected at indicated timepoints and pharmacokinetic (PK) analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.
Cmax was defined as maximum observed post-dose plasma concentration for diphenhydramine obtained without interpolation. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.
AUC (0-t) was defined as the area under the plasma concentration versus time curve calculated from time zero to the last measurable sampling time point, (t) using linear up log down trapezoidal method. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.
AUC (0-t) was defined as the area under the plasma concentration versus time curve calculated from time zero to the last measurable sampling time point, (t) using linear up log down trapezoidal method. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC0-inf = AUC0-t + C(last)/λz where C(last) was the concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity computed as AUC0-inf = AUC0-t + C(last)/λz where C(last) was the concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints and PK analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.
| Arm | Type | Description |
|---|---|---|
| Advil PM Liqui-Gels Minis | EXPERIMENTAL | Participants will be randomly assigned as per cross-over design to receive a single dose of 2 Advil PM Liqui-Gels Minis capsules orally on day 1 of period 1 and will receive single dose of 2 Advil PM Liqui-Gels capsules orally on day 1 of period 2 with at least 7 days washout period. Participants will be instructed to consume the entire amount of ambient temperature water (approximately 240 milliliters \[mL\]) along their investigational product. |
| Advil PM Liqui-Gels | ACTIVE_COMPARATOR | Participants will be randomly assigned as per cross-over design to receive a single dose of 2 Advil PM Liqui-Gels capsules orally on day 1 of period 1 and will receive single dose of 2 Advil PM Liqui-Gels Minis capsules orally on day 1 of period 2 with at least 7 days washout period. Participants will be instructed to consume the entire amount of ambient temperature water (approximately 240 mL) along their investigational product. |
| Name | Type | Description |
|---|---|---|
| Advil PM Liqui-Gels Minis | DRUG | Ibuprofen/diphenhydramine hydrochloride 200 mg/25 mg, Oral capsule which is a size reduction of the currently marketed reference product. |
| Advil PM Liqui-Gels | DRUG | Ibuprofen/diphenhydramine hydrochloride 200 mg/25 mg, Oral capsule. |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Participant who is willing and able to comply with scheduled visits, treatment plan...
Advil PM Liqui-Gels Minis is a small molecule drug used for pain. It is a combination of ibuprofen and diphenhydramine hydrochloride, each 200 mg/25 mg, and is being developed by Haleon plc. The drug is currently in Phase 1 clinical development as an investigational product.
Advil PM Liqui-Gels Minis is developed by Haleon plc, a company traded under the ticker HLN. The drug is a small molecule combination of ibuprofen and diphenhydramine hydrochloride, intended for the treatment of pain. It is currently in Phase 1 clinical development.
Advil PM Liqui-Gels Minis is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for pain and is a small molecule combination of ibuprofen and diphenhydramine hydrochloride.
Advil PM Liqui-Gels Minis has one completed clinical trial, identified as NCT05674721. This was a Phase 1 bioequivalence study comparing the drug to the current marketed Advil PM Liqui-Gels in healthy adult subjects under fasted conditions. The trial enrolled 77 participants in the United States.
Advil PM Liqui-Gels Minis is a new formulation being compared to the current marketed Advil PM Liqui-Gels. Both contain ibuprofen and diphenhydramine hydrochloride at 200 mg/25 mg. The Phase 1 trial NCT05674721 was designed to assess bioequivalence between the two products.