Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever FDA label
Also known as Advil Tablet (Mini) (Test Product)
Advil · 1 trial · 2 indications
Cmax is defined as the maximum observed post-dose concentration obtained without interpolation. Blood samples will be collected at indicated timepoints for the analysis of Cmax.
AUC(0-t) is defined as the area under the plasma concentration versus time curve calculated from time 0 to the last measurable sampling time point, t, computed using the linear trapezoidal rule. Blood samples will be collected at indicated timepoints for the analysis of AUC(0-t).
Cmax is defined as the maximum observed post-dose concentration obtained without interpolation. Blood samples will be collected at indicated timepoints for the analysis of Cmax.
AUC(0-t) is defined as the area under the plasma concentration versus time curve calculated from time 0 to the last measurable sampling time point, t, computed using the linear trapezoidal rule. Blood samples will be collected at indicated timepoints for the analysis of AUC(0-t).
AUC(0-inf) is defined as the area under the plasma concentration versus time curve calculated from time 0 to infinity. AUC(0-inf) = AUC(0-t) + C(t)/λz where C(t) is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Blood samples will be collected at indicated timepoints for the analysis of AUC(0-inf).
| Arm | Type | Description |
|---|---|---|
| Sequence 1: Treatment A/ Treatment B/ Treatment C | EXPERIMENTAL | Participants will receive a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 3 (Treatment C). There will be a washout period of at least 3 days between each treatment. |
| Sequence 2: Treatment B/ Treatment C/ Treatment A | EXPERIMENTAL | Participants will receive a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 2 (Treatment C), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 3 (Treatment A). There will be a washout period of at least 3 days between each treatment. |
| Sequence 3: Treatment C/ Treatment A/ Treatment B | EXPERIMENTAL | Participants will receive a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 1 (Treatment C), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 3 (Treatment B). There will be a washout period of at least 3 days between each treatment. |
| Sequence 4: Treatment A/ Treatment C/ Treatment B | EXPERIMENTAL | Participants will receive a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 2 (Treatment C), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 3 (Treatment B). There will be a washout period of at least 3 days between each treatment. |
| Sequence 5: Treatment B/ Treatment A/ Treatment C | EXPERIMENTAL | Participants will receive a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of Advil (Mini) under fed conditions on Day 1 of Period 3 (Treatment C). There will be a washout period of at least 3 days between each treatment. |
| Sequence 6: Treatment C/ Treatment B/ Treatment A | EXPERIMENTAL | Participants will receive a single oral dose of Advil (Mini) under fed conditions on Day 1 of Period 1 (Treatment C), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 3 (Treatment A). There will be a washout period of at least 3 days between each treatment. |
| Name | Type | Description |
|---|---|---|
| Advil Tablet (Mini) (Test Product) | DRUG | 200 mg Ibuprofen |
| Advil Tablet (Reference Product) | DRUG | 200 mg Ibuprofen |
Inclusion Criteria: * Participant provision of a signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * A participant whose biological sex at birth is male or female. * A participant ...
Advil is a small molecule medicine developed by Haleon plc (ticker HLN). It is being studied in a Phase 1 clinical program, with one completed trial. The specific therapeutic indication for this asset is undisclosed, and the therapeutic area is classified as Other.
Advil is developed by Haleon plc, which trades under the ticker HLN. Haleon is the company responsible for the clinical development of Advil, including the completed Phase 1 trial of Advil Tablet (Mini) (Ibuprofen 200 mg).
Advil is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The program includes a total enrollment of 68 participants across the completed study.
Advil has been evaluated in one completed Phase 1 trial, NCT07345130. This was a bioequivalence and bioavailability study of Advil Tablet (Mini) (Ibuprofen 200 mg) versus Advil Tablet (Ibuprofen 200 mg) in healthy adult subjects, conducted in the United States under fasted and fed conditions.
Advil is also known as Advil Tablet (Mini) (Test Product). This alternative name refers to the same asset developed by Haleon plc. The completed Phase 1 trial NCT07345130 specifically compared Advil Tablet (Mini) (Ibuprofen 200 mg) with Advil Tablet (Ibuprofen 200 mg).