The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to see if two different forms of the medication react the same way in the human body. This study will look at biological samples from people who take an orally disintegrating tablet of dexlansoprazole compared to a swallowed capsule of dexlansoprazole. The study will enroll approximately 52 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups. Both treatment groups will receive both forms of dexlansoprazole at different time periods: * Two dexlansoprazole 30 mg orally disintegrating tablets for 5 days * One dexlansoprazole 60 mg capsule for 5 days. All participants will be asked to take two tablets or one capsule at the same time each day throughout each treatment period of the study. This single-centre trial will be conducted in the United States. Participants will make 3 visits to the clinic including two 6-day periods of confinement to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment. The overall time to participate in this study is up to 57 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Dexlansoprazole delayed-release, orally disintegrating (OD) tablets
Dexlansoprazole delayed-release capsules
Unnamed facility
Tempe, Arizona, United States
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Day 1 predose and up to 24 hours post-dose
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Day 5 predose and up to 24 hours post-dose
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.
Time frame: Day 1 predose and up to 24 hours post-dose
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.
Time frame: Day 5 predose and up to 24 hours post-dose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1
AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.
Time frame: Day 1 predose and up to 24 hours post-dose
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5
AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours).
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Time frame: Day 5 predose and up to 24 hours post-dose