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Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects.
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Drug: CJ-12420 200mg Period1: CJ-12420 under fed condition Period2: CJ-12420 under fasting condition |
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| Sequence 2 | Experimental | Drug: CJ-12420 200mg Period1: CJ-12420 under fasting condition Period2: CJ-12420 under fed condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-12420 200mg | Drug | Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean ratio and 90% CI for log-transformed AUClast | Blood sampling during 24 or 48 hrs after administration | |
| Geometric mean ratio and 90% CI for log-transformed Cmax | Blood sampling during 24 or 48 hrs after administration |
| Measure | Description | Time Frame |
|---|---|---|
| time pH > 4 | 24 hour before and after IP administration |
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Inclusion Criteria:
Male volunteers in the age between 20 and 45 years old(inclusive)
Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg (inclusive)
Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate)
Understand the requirements of the study and voluntarily consent to participate in the study
Exclusion Criteria:
Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group.
The following criteria will be applied ONLY to PD/PK group
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae, MD, Ph.D | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34246485 | Derived | Han S, Choi HY, Kim YH, Nam JY, Kim B, Song GS, Lim HS, Bae KS. Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Tegoprazan. Clin Ther. 2021 Aug;43(8):1371-1380. doi: 10.1016/j.clinthera.2021.06.007. Epub 2021 Jul 8. |
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