The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
The drug being tested in this study is called Dexlansoprazole. This study will assess the pharmacokinetics, safety and tolerability of a single oral dose of Dexlansoprazole 30 mg and 60 mg delayed-release capsules in healthy participants. The study will enroll approximately 40 participants, 20 participants in each parallel arm. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups: * Group 1: A single oral dose of Dexlansoprazole 30 mg delayed-release capsule * Group 2: A single oral dose of Dexlansoprazole 60 mg delayed-release capsule All participants will be asked to take single dose of study drug on Day 1. This single center trial will be conducted in China. The overall time to participate in this study is approximately 40 days. Participants will be contacted by telephone or will make a final visit to the clinic 5 to 10 days after receiving their last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Dexlansoprazole delayed-release capsule.
Phase I Clinical Trial Department
Beijing, Beijing Municipality, China
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.