A Phase 1 interventional study of Vonoprazan Test 20mg and Vonoprazan Reference 20mg in Gastric Ulcer, sponsored by Hanlim Pharm. Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Hanlim Pharm. Co., Ltd. · Phase 1, Interventional, and Other
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.
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.
112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.
This study's enrollment of 30 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.
Browse Stomach Ulcer studies →Hanlim Pharm. Co., Ltd. is the lead sponsor of 49 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individuals who have engaged in excessive alcohol consumption within one month before the start of the study (first dosing day)
Patients with the following conditions:
Individuals who do not agree to use medically recognized dual contraception* methods, excluding hormonal contraceptives, to prevent pregnancy from the first administration of the investigational drug until one week after the last administration of the investigational drug.
On the day of the visit, take 1 tablet of the experimental drug orally with 150 mL of water around 8 am.
Drug: Vonoprazan Test 20mg
On the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am.
Drug: Vonoprazan Reference 20mg
1 tablets orally once a day
Also known as: vonoprazan fumarate
1 tablets orally once a day
Also known as: Vonoprazna fumarate
Peak Plasma Concentration (Cmax)
Concentration of vonoprazan in plasma
Time frame: 36 hours
Area under the plasma concentration versus time curve (AUC)
Concentration of vonoprazan in plasma
Time frame: 36 hours
AUCt/AUC∞
Concentration of vonoprazan in plasma
Time frame: 36 hours
Half life
Concentration of vonoprazan in plasma
Time frame: 36 hours
Tmax
Concentration of vonoprazan in plasma
Time frame: 36 hours
AUC ∞
Concentration of vonoprazan in plasma
Time frame: 36 hours
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hanlim Pharm. Co., Ltd.