| Primary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan | | Measured in the pharmacokinetic (PK) population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•h/mL | | Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. | | | | ID | Title | Description |
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| OG000 | Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG001 | Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG002 | Treatment C: Vonoprazan 20 mg Tablet | Participants received vonoprazan 20 mg orally as a tablet on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000228± 44.9
- OG001216± 46.0
- OG002219± 47.3
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Ratio of Geometric Least Square Means | 103.36 | | | 2-Sided | 90 | 97.64 | 109.41 | | | | | Equivalence | Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters. | | |
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| Primary | Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan | | Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•h/mL | | Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. | | | | ID | Title | Description |
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| OG000 | Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG001 | Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG002 | Treatment C: Vonoprazan 20 mg Tablet |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Vonoprazan | | Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. | | | | ID | Title | Description |
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| OG000 | Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG001 | Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG002 | Treatment C: Vonoprazan 20 mg Tablet |
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| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Vonoprazan | | Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified. | Posted | | Median | Full Range | hours | | Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. | | | | ID | Title | Description |
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| OG000 | Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG001 | Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG002 | Treatment C: Vonoprazan 20 mg Tablet | |
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| Secondary | Terminal Phase Half-life (t1/2) of Vonoprazan | | Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. | | | | ID | Title | Description |
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| OG000 | Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG001 | Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG002 | Treatment C: Vonoprazan 20 mg Tablet |
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| Secondary | Apparent Total Body Clearance (CL/F) of Vonoprazan | | Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified. | Posted | | Geometric Mean | Geometric Coefficient of Variation | litres/h | | Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. | | | | ID | Title | Description |
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| OG000 | Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG001 | Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG002 | Treatment C: Vonoprazan 20 mg Tablet |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Vonoprazan | | Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified. | Posted | | Geometric Mean | Geometric Coefficient of Variation | litres | | Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. | | | | ID | Title | Description |
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| OG000 | Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG001 | Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG002 | Treatment C: Vonoprazan 20 mg Tablet |
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| Secondary | Terminal Elimination Rate Constant (λz) of Vonoprazan | | Measured in the PK population, which included all participants who received at least 1 dose of vonoprazan and had sufficient concentration data to support accurate estimation of at least 1 PK parameter. PK data are presented for each treatment received, as pre-specified. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/h | | Day 1 of each 3-day Treatment Period: Within 0.25 hours pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose. | | | | ID | Title | Description |
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| OG000 | Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of pudding on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG001 | Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce | Participants received vonoprazan 20 mg orally as a sprinkle capsule on 1 tablespoon of applesauce on Day 1 of their assigned Treatment Period. Which treatment the participants received in each Treatment Period was dependent upon which Treatment Sequence they were assigned to at randomization. | | OG002 | Treatment C: Vonoprazan 20 mg Tablet |
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