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Study objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| CJ-12406 | Experimental | CJ-12406 Tablet, daily for 1 day or bid for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | single and multiple dose |
| |
| CJ-12406 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of CJ-12406 | Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9. | 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose |
| Number of participants with adverse events | A range of 17 days - from screening to gollow-up visit | |
| Peak plasma concentration (Cmax) of CJ-12406 | Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9. | 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose |
| Area under the plasma concentration versus time curve (AUC) of active metabolite | Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9. | 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose |
| Peak plasma concentration (Cmax) of active metabolite | Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9. |
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori eradication rate | UBT test | 38 days post dose (plus of minus 1 day) |
| The percent time of intragastric pH>4 | 7 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
History of clinically significant allergies including drug allergies
History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
Symptom of an acute illness within 4 weeks prior to drug administration
History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration
Clinical laboratory test values are outside the accepted normal range
Clinically significant vital signs
History of drug and alcohol abuse(alcohol > 30 g/day)
Subjects who have ever smoke within 3 months prior to drug administration
Positive urine screen for drugs and cotinine
Use of any other medication, including herbal products, within the 2 weeks before dosing
Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
Donated blood within 60 days prior to dosing
Participated in a previous clinical trial within 90 days prior to dosing
Subjects considered as unsuitable based on medical judgement by investigators
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Gook Shin, MD. PhD | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 614-735 | South Korea |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Drug |
single and multiple dose |
|
| 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose |