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Label indication NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) • Maintenance of healing of EE in adults. FDA label
Esomeprazole · 1 trial · 1 indication
Cmax is defined as maximum observed post-dose concentration; obtained without interpolation. Blood samples were collected at the indicated time points for the analysis of Cmax. Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis.
AUC(0-t) is defined as 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 were collected at the indicated time points for the analysis of AUC0-t. PK parameters were calculated by standard non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Test Product/Reference Product | EXPERIMENTAL | Participants will be randomly assigned to receive Esomeprazole 20 mg delayed-release one capsule once daily as oral administration on day 1 of period 1 and will receive Esomeprazole 20 mg delayed-release one capsule (Nexium 24HR) once daily as oral administration on day 1 of period 2. Participants are instructed to consume the entire amount of ambient temperature water (240 milliliter \[mL\]) along their investigational product. There will be washout period of 7 days between two treatment periods. |
| Reference Product/Test Products | EXPERIMENTAL | Participants will be randomly assigned to receive Esomeprazole 20 mg delayed-release one capsule (Nexium 24HR) once daily as oral administration on day 1 of period 1 and will receive Esomeprazole 20 mg delayed-release one capsule once daily as oral administration on day 1 of period 2. Participants are instructed to consume the entire amount of ambient temperature water (240 milliliter \[mL\]) along their investigational product. There will be washout period of 7 days between two treatment periods. |
| Name | Type | Description |
|---|---|---|
| Esomeprazole 20 mg Delayed-Release Capsules | DRUG | Esomeprazole 20 mg delayed-release capsules will be given as one capsule once daily as oral administration. |
| Esomeprazole 20 mg Delayed-Release Capsules (Nexium 24HR) | DRUG | Esomeprazole 20 mg delayed-release capsules (Nexium 24HR) will be given as one capsule once daily as oral administration. |
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...
Esomeprazole is a small molecule developed for gastrointestinal diseases. Haleon plc is developing esomeprazole 20 mg delayed-release capsules, and the clinical program has focused on bioequivalence testing in healthy adult participants rather than on a specific approved patient indication.
Esomeprazole targets ATP4A and ATP4B. It acts as an inhibitor of these targets, which are components of the gastric proton pump. This target class places esomeprazole among proton pump inhibitors used in gastrointestinal medicine.
Haleon plc, which trades under the ticker HLN, is the developer of esomeprazole 20 mg delayed-release capsules. The company is responsible for the clinical development program for this formulation.
Esomeprazole 20 mg delayed-release capsules are in Phase 1 development. The program includes one completed Phase 1 trial, and no active trials are ongoing. The drug is investigational and is not described as approved.
Esomeprazole has been studied in one completed Phase 1 trial, NCT05265247, titled a bioequivalence study of esomeprazole 20 mg delayed-release capsules in healthy adult participants. It enrolled 61 participants in Canada, was randomized, double-blind, and controlled, and included healthy volunteers aged 18 years and older.