The aim of this study is to evaluate the pharmacokinetic (PK) profile of vonoprazan (10 or 20 mg once daily \[QD\]) in children ≥ 6 to \< 12 years of age who have symptomatic Gastroesophageal Reflux Disease (GERD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Administered orally
Strada Patient Care Center
Mobile, Alabama, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Med Research Associates, Inc
Hollywood, Florida, United States
Maximum Drug Concentration at Steady-state (Cmax,ss) of Vonoprazan
Plasma pharmacokinetic (PK) parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Time frame: Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
Area Under the Plasma Concentration-time Curve During the Dosing Interval τ at Steady State (AUCτ,ss) of Vonoprazan
Plasma PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Time frame: Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
Apparent Oral Clearance (CL/F) at Steady State of Vonoprazan
Oral PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Time frame: Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose
Apparent Central Volume of Distribution (Vz/F) at Steady State of Vonoprazan
Plasma PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
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Avanza Medical Research Center
Pensacola, Florida, United States
International Center for Research
Tampa, Florida, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, United States
Advantage Clinical Trials
The Bronx, New York, United States
PriMED Clinical Research
Dayton, Ohio, United States
...and 3 more locations
Time frame: Day 7: pre-dose, 0.5 to 1.5 hour and 2.5 to 3.5 hours post dose; Day 14: pre-dose, 1 to 2 hours and 3 to 4 hours post dose