Recent Updates
Recently added Catalysts

Esomeprazole

Phase 1

Gastrointestinal Diseases | Small molecule | Gastrointestinal |Haleon plc|Last Updated: Feb 5, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

Esomeprazole · 1 trial · 1 indication

Phase 1 1
NCT05265247Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult ParticipantsGastrointestinal Diseases
COMPLETED61 Analytics
PHASE1COMPLETED
Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult Participants
Gastrointestinal Diseases
NCT0526524761
Unlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Post Dose Concentration (Cmax)
Pre-dose (within 1 hour prior to dosing), 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,10, 12, 16, and 24 hours post dose in each treatment period (each period is of 2 days)

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.

Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to the Last Measurable Sampling Time Point
Pre-dose (within 1 hour prior to dosing), 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,10, 12, 16, and 24 hours post dose in each treatment period (each period is of 2 days)

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.

Secondary Endpoints

Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to Infinity (AUC0-inf)
Pre-dose (within 1 hour prior to dosing), 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,10, 12, 16, and 24 hours post dose in each treatment period (each period is of 2 days)
Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)
Pre-dose (within 1 hour prior to dosing), 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,10, 12, 16, and 24 hours post dose in each treatment period (each period is of 2 days)
Terminal Elimination Rate Constant
Pre-dose (within 1 hour prior to dosing), 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8,10, 12, 16, and 24 hours post dose in each treatment period (each period is of 2 days)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Test Product/Reference ProductEXPERIMENTALParticipants 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 ProductsEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
Esomeprazole 20 mg Delayed-Release CapsulesDRUGEsomeprazole 20 mg delayed-release capsules will be given as one capsule once daily as oral administration.
Esomeprazole 20 mg Delayed-Release Capsules (Nexium 24HR)DRUGEsomeprazole 20 mg delayed-release capsules (Nexium 24HR) will be given as one capsule once daily as oral administration.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Canada
Unlock Eligibility Criteria