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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonoprazan Test 20mg | Experimental | On the day of the visit, take 1 tablet of the experimental drug orally with 150 mL of water around 8 am. |
|
| Vonoprazan Reference 20mg | Active Comparator | On the day of the visit, take 1 tablet of the comparator drug orally with 150 mL of water around 8 am. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan Test 20mg | Drug | 1 tablets orally once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Concentration of vonoprazan in plasma | 36 hours |
| Area under the plasma concentration versus time curve (AUC) | Concentration of vonoprazan in plasma | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt/AUC∞ | Concentration of vonoprazan in plasma | 36 hours |
| Half life | Concentration of vonoprazan in plasma | 36 hours |
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Inclusion Criteria:
Exclusion Criteria:
Individuals who have taken enzyme-inducing or inhibiting drugs such as barbiturates within 30 days before the start of the study (first dosing day) or medications that might interfere with the study within 10 days before the start of the study (first dosing day)
Individuals who have engaged in excessive alcohol consumption within one month before the start of the study (first dosing day)
Individuals who have taken any medication that may interfere with the trial within 10 days prior to the start of the trial (first dose).
Individuals who have participated in clinical trials (including bioequivalence studies) and received investigational drugs within six months before the start of the study (first dosing day)
Individuals who have donated whole blood within 8 weeks or donated blood components within 2 weeks before the start of the study (first dosing day)
Patients with the following conditions:
Individuals with a history of mental illness
Women who may be pregnant, pregnant women, or brestfeeding women
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.
- Medically recognized dual contraception methods: Combining intrauterine devices (IUD, IUS), vasectomy, tubal ligation, and barrier methods of contraception (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or using two or more barrier methods in combination with spermicides.
Individuals deemed unsuitable for this clinical trial for reasons other than the above inclusion/exclusion criteria by the principal investigator (or a designated sub-investigator)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seok Gyeong Medical Foundation Central Hospital | Siheung-si | South Korea |
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| Vonoprazan Reference 20mg | Drug | 1 tablets orally once a day |
|
|
| Tmax | Concentration of vonoprazan in plasma | 36 hours |
| AUC ∞ | Concentration of vonoprazan in plasma | 36 hours |
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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