The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of two vonoprazan orally disintegrating tablet formulations (ODT-1 or ODT-2) administered without water or mixed with water and administered via a syringe relative to the vonoprazan tablet in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
25
Vonoprazan will be administered orally as an ODT-1 or ODT-2 without water
Vonoprazan will be administered orally as an ODT-1 or ODT-2 with water via a syringe
Vonoprazan will be administered orally as a tablet
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Maximum Observed Drug Concentration (Cmax) of Vonoprazan
Cmax of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes 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 to the Last Quantifiable Concentration (AUC0-t) of Vonoprazan
AUC0-t of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of Vonoprazan
AUC0-inf of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes 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
Tmax of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes 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 Until First Measurable Concentration in Plasma (Tlag) of Vonoprazan
Tlag of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes 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 Elimination Rate Constant (λz) of Vonoprazan
λz of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes 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 Phase Half-life (t1/2) of Vonoprazan
t1/2 of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes 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 Oral Clearance (CL/F) of Vonoprazan
CL/F of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes 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
Vz/F of Vonoprazan was reported.
Time frame: Day 1 of each 3-day treatment period: Within 15 minutes pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose