Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare and evaluate impact on pharmacodynamic characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male volunteers
Evaluation Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420 50mg | Experimental | T1=CJ-12420 50mg QD evening (9PM) |
|
| CJ-12420 100mg | Experimental | T2=CJ-12420 100mg QD evening (9PM) |
|
| CJ-12420 200mg | Experimental | T3=CJ-12420 200mg QD evening (9PM) |
|
| Dexlansopazole 60mg | Active Comparator | R=dexlansoprazole 60mg QD evening (9p.m) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole 60 MG | Drug |
|
| |
| CJ-12420 50mg |
| Measure | Description | Time Frame |
|---|---|---|
| Time pH > 4 of CJ-12420 | intragastric pH | 24 hours pH |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of CJ-12420 | maximum measured plasma concentraion | up to 20 hours |
| AUClast of CJ-12420 | The area under the plasma concentration versus time curve from time 0 to the last measurable concentration |
Not provided
Inclusion Criteria:
Healthy male volunteers aged ≥20 to ≤45 years
Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg
Medically healthy without clinically significant vital signs (blood pressure in sitting position, heart rate)
Understand restriction during the study and voluntarily consent to participate in the study
Consent to use the effective contraceptive methods (using abstinence, spermicide, and condom) and not to donate sperm during the study and until 30 days after completion of study
Non-smoker or ex-smoker who stopped smoking for at least one year
Negative H. pylori result in urea breath test (UBT)
Exclusion Criteria:
Healthy male volunteers
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eunji Kim | CJ HealthCare Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| D014284 | Triiodothyronine |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| CJ-12420 100mg | Drug |
|
|
| CJ-12420 200mg | Drug |
|
|
| up to 20 hours |
| Cmax of dexlansoprazole | maximum measured plasma concentraion | up to 20 hours |
| AUClast of dexlansoprazole | The area under the plasma concentration versus time curve from time 0 to the last measurable concentration | up to 20 hours |
| Time pH > 4 of dexlansoprazole | intragastric pH | 24 hours pH |
| Median pH > 4 of CJ-12420 | intragastric pH | 24 hours pH |
| Median pH > 4 of dexlansoprazole | intragastric pH | 24 hours pH |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013970 | Thyronines |
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013974 | Thyroxine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |