The main purpose of this study is to explore the pharmacokinetics, pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects.
* To explore the pharmacokinetics, pharmacodynamics and safety in accordance with the dose escalation when tegoprazan is given orally twice daily for 3 days in healthy subjects. * To compare the pharmacodynamics and safety of tegoprazan oral administration and esomeprazole infusion for 24 hours
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Tegoprazan A mg or placebo taken orally twice daily for 3 days.
Tegoprazan B mg or placebo taken orally twice daily for 3 days.
Tegoprazan C mg or placebo taken orally twice daily for 3 days.
Inje University Busan Paik Hospital
Busan, South Korea
RECRUITINGPharmacokinetics Evaluation
Cmax of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
AUC0-t of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
AUC0-∞ of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
Tmax of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
t1/2β of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
CL/F of Tegoprazan
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
Vd/F of Tegoprazan
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
Css,max of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
Css,min of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetic Evaluation
Css,avg of Tegoprazan and M1
Time frame: Up to 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tegoprazan D mg or placebo taken orally twice daily for 3 days.
Pharmacokinetics Evaluation
AUC48-72h of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
Tmax,ss of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
t1/2β,ss of Tegoprazan and M1
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
CLss/F of Tegoprazan
Time frame: Up to 24 hours
Pharmacokinetics Evaluation
Vdss/F of Tegoprazan
Time frame: Up to 24 hours
Pharmacodynamics Evaluation
Mean pH
Time frame: 24 hours
Pharmacodynamics Evaluation
Median pH
Time frame: 24 hours
Pharmacodynamics Evaluation
TpH\>4(%)
Time frame: 24 hours
Pharmacodynamics Evaluation
TpH\>6(%)
Time frame: 24 hours
Pharmacodynamics Evaluation
Basal pH
Time frame: 24 hours
Pharmacodynamics Evaluation
Δ TpH\>4(%)
Time frame: 24 hours
Pharmacodynamics Evaluation
Δ TpH\>6(%)
Time frame: 24 hours
Pharmacodynamics Evaluation
Δ mean pH
Time frame: 24 hours
Pharmacodynamics Evaluation
Δ median pH
Time frame: 24 hours