A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects
* To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males. * To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males. * To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
44
Tegoprazan QD, oral administration. Treatment A
Tegoprazan QD, oral administration. Treatment B
Tegoprazan BID, oral administration
Seoul National University Hospital
Seoul, South Korea
RECRUITINGAUC(0-24h) of tegoprazan
Area Under the Curve(0-24h) of tegoprazan
Time frame: up to 7 days
Cmax of tegoprazan
Maximum Plasma Concentration of tegoprazan
Time frame: up to 7 days
Gastric pH
Gastric pH
Time frame: up to 7 days
Serum gastrin concentration
Serum gastrin concentration
Time frame: up to 7 days
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Tegoprazan QD, oral administration, for 7 days. Group 1
Tegoprazan QD, oral administration, for 7 days. Group 2
Esomeprazole QD, oral administration, for 7 days. Group 3
Tegoprazan QD, oral administration