Seok Gyeong Medical Foundation Central Hospital
Siheung-si, South Korea
NCT Number: NCT06642987
This clinical trial is an open-label, randomized, fasting, single-dose, two-sequence, two-period, crossover study in healthy subjects to evaluate the bioequivalence of "Vonopzan Tablets 20 mg(Vonoprazan Fumarate)" of Hanlim Pharm.l Co., Ltd. and "Vocinti Tablet 20 mg (Vonoprazan Fumarate)" of Takeda Pharmaceuticals Korea Co., Ltd. in Healthy Adult Subjects.
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Notify Me19 year and older
All sexes
Interventional
Phase 1
Siheung-si, South Korea
This study is to compare and evaluate the safety and pharmacokinetic characteristics of "Vonopzan Tablets 20 mg(Vonoprazan Fumarate)" of Hanlim Pharm. Co., Ltd. as the test drug and "Vocinti Tablet 20 mg (Vonoprazan Fumarate)" of Takeda Pharmaceuticals Korea Co., Ltd. as the reference drug in healthy adults.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 tablets orally once a day
Other names: vonoprazan fumarate
1 tablets orally once a day
Other names: Vonoprazna fumarate
Time frame: 36 hours
Concentration of vonoprazan in plasma
Time frame: 36 hours
Concentration of vonoprazan in plasma
Time frame: 36 hours
Concentration of vonoprazan in plasma
Time frame: 36 hours
Concentration of vonoprazan in plasma
Time frame: 36 hours
Concentration of vonoprazan in plasma
Time frame: 36 hours
Concentration of vonoprazan in plasma
Hanlim Pharm. Co., Ltd.
Industry
An Open-label, Randomized, Fasting, Single-dose, 2x2, Crossover Study in Healthy Subjects to Evaluate the Bioequivalence of Vonopzan Tablets 20mg(Vonoprazan Fumarate) of Hanlim and Vocinti Tablet 20mg(Vonoprazan Fumarate) of Takeda.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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