This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.
A open-label, randomized, multiple dose, two arm, two period, crossover study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Tegoprazan 50 mg tablet
Metronidazole 250 mg tablet
Tetracycline hydrochloride 250 mg capsule
Chonbuk National University Hospital
Jeonju, South Korea
AUC0-12 of tegaprazan and metabolite M1
Area under the plasma concentration versus time curve of tegoprazan
Time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Cmax of tegaprazan and metabolite M1
Peak Plasma Concentration of tegoprazan and metabolite M1
Time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
AUC0-6 of metronidazole, tetracycline and bismuth
Area under the plasma concentration versus time curve of metronidazole, tetracycline and bismuth
Time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
Cmax of metronidazole, tetracycline and bismuth
Peak Plasma Concentration of metronidazole, tetracycline and bismuth
Time frame: pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.
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Tripotassium bismuth dicitrate 300 mg tablet