The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of vonoprazan 20 mg sprinkle capsule, either sprinkled on pudding or on applesauce, relative to a vonoprazan 20 mg tablet in healthy participants.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
27
Orally via tablet
Orally via sprinkle pellets
PPD Development, LP
Austin, Texas, United States
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
Time frame: 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.
Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
Time frame: 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.
Maximum Observed Plasma Concentration (Cmax) of Vonoprazan
Time frame: 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.
Time to Maximum Observed Plasma Concentration (Tmax) of Vonoprazan
Time frame: 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.
Terminal Phase Half-life (t1/2) of Vonoprazan
Time frame: 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.
Apparent Total Body Clearance (CL/F) of Vonoprazan
Time frame: 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.
Apparent Volume of Distribution (Vz/F) of Vonoprazan
Time frame: 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.
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Terminal Elimination Rate Constant (λz) of Vonoprazan
Time frame: 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.