Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ADA Liquid Filled Capsules (Test Product)
ADA Liquid Filled · 1 trial · 1 indication
Cmax is defined as the maximum observed post-dose concentration for ibuprofen 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 for acetaminophen 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 for ibuprofen 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).
Cmax is defined as the maximum observed post-dose concentration for acetaminophen 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 + Treatment D | EXPERIMENTAL | Participants will receive a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 3 (Treatment C) and further followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 4 (Treatment D). There will be a washout period of at least 3 days between each treatment. |
| Sequence 2: Treatment B + Treatment D + Treatment A + Treatment C | EXPERIMENTAL | Participants will receive a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 2 (Treatment D), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 3 (Treatment A) and further followed by a single oral dose of ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 4 (Treatment C). There will be a washout period of at least 3 days between each treatment. |
| Sequence 3: Treatment C + Treatment A + Treatment D + Treatment B | EXPERIMENTAL | Participants will receive a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 1 (Treatment C), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 3 (Treatment D) and further followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 4 (Treatment B). There will be a washout period of at least 3 days between each treatment. |
| Sequence 4: Treatment D + Treatment C + Treatment B + Treatment A | EXPERIMENTAL | Participants will receive a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 1 (Treatment D), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 2 (Treatment C), followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 3 (Treatment B), and further followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 4 (Treatment A). There will be a washout period of at least 3 days between each treatment. |
| Name | Type | Description |
|---|---|---|
| ADA Liquid Filled Capsules (Test Product) | DRUG | ADA liquid filled capsules containing 125 mg ibuprofen and 250 mg acetaminophen. |
| ADA Caplets (Reference Product) | DRUG | ADA Caplets containing 125 mg ibuprofen and 250 mg acetaminophen. |
| Advil Liqui-gels (Reference Product) | DRUG | Advil Liqui-gels containing 200 mg ibuprofen. |
Inclusion Criteria: * Participant provision of a 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 is male or female who, at the time of screening, is between the ages ...
ADA Liquid Filled is an investigational small molecule product developed by Haleon plc for pain. It is also known as ADA Liquid Filled Capsules (Test Product). The product has been studied in a Phase 1 bioequivalence trial in healthy adult subjects.
ADA Liquid Filled is being developed for the treatment of pain. The Phase 1 trial in healthy adult subjects listed pain as the condition under study. The product is investigational and has not been approved for any indication.
ADA Liquid Filled is developed by Haleon plc, which trades under the ticker HLN. Haleon is the company responsible for the clinical development of this investigational pain product.
ADA Liquid Filled is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The product remains investigational and has not been approved by the FDA.
ADA Liquid Filled has been evaluated in one completed Phase 1 trial, NCT06802185. This was a bioequivalence and bioavailability study of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) versus Advil Dual Action Caplets (125 mg/250 mg) and Advil Liqui-Gels (200 mg) in 54 healthy adult subjects in the United States.
Yes, ADA Liquid Filled is also known as ADA Liquid Filled Capsules (Test Product). The alternative name refers to the same investigational product developed by Haleon plc for pain.