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This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Part I: A-B-D-C A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid |
|
| Sequence 2 | Experimental | Part I: B-C-A-D A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid |
|
| Sequence 3 | Experimental | Part I: C-D-B-A A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid |
|
| Sequence 4 | Experimental | Part I: D-A-C-B A: DWP14012 A mg bid B: DWP14012 A mg bid + Clarithromycin 500 mg bid C: DWP14012 A mg bid + Clarithromycin 500 mg bid + Amoxicillin 1 g bid D: Clarithromycin 500 mg bid + Amoxicillin 1 g bid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 Amg | Drug | DWP14012 Amg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state | Part I: each period (Group A, B, C, D) Part II: Group A, B | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours |
| Cmin,ss: Minimum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state | Part I: each period (Group A, B, C, D) Part II: Group A, B | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours |
| Cav,ss: Average concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state | Part I: each period (Group A, B, C, D) Part II: Group A, B | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours |
| AUCt,ss: Area under the drug concentration-time curve within a dosing interval at steady states | Part I: each period (Group A, B, C, D) Part II: Group A, B | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours |
| Tmax,ss: Time of maximum concentration at steady state | Part I: each period (Group A, B, C, D) Part II: Group A, B | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours |
| T1/2: Elimination half-life | Part I: each period (Group A, B, C, D) Part II: Group A, B | Day 1~7 pre-dose, Day 8 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| A |
| Experimental |
Part II: (DWP14012 B mg + Clarithromycin 500 mg + Amoxicillin 1g) bid |
|
| B | Experimental | Part II: (DWP14012 A mg + Clarithromycin 500 mg + Amoxicillin 1g) bid |
|
| C | Experimental | Part II: (Lansoprazole 30 mg + Clarithromycin 500 mg + Amoxicillin 1g) bid |
|
| DWP14012 Bmg | Drug | DWP14012 Bmg |
|
| Clarithromycin | Drug | Clarithromycin 500 mg |
|
| Amoxicillin | Drug | Amoxicillin 1 g |
|
| Lansoprazole | Drug | Lansoprazole 30 mg |
|
| Percentage of total time that the intragastric pH was above 4 | Part I | Period 1 Day -1 and Group A, C Day 7 0~24 hours |
| Percentage of total time that the intragastric pH was above 4 | Part II | Day -1, Day 1, Day 7 0~24 hours |
| Percentage of total time that the intragastric pH was above 6 | Part I | Period 1 day -1 and Group A, C Day 7 0~24 hours |
| Percentage of total time that the intragastric pH was above 6 | Part II | Day -1, Day 1, Day 7 0~24 hours |
| Serum gastrin concentration profile | Part I | Period 1 Day -1 and Group A, C Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours |
| Serum gastrin concentration profile | Part II | Day -1 pre-dose, 2, 4, 6, 8, 12 hours, Day 1 and 7 pre-dose, 2, 4, 6, 8, 12, 24, 48 hours |
| Number of participants with Adverse Events (AE) | All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate and severe | Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II) |
| Number of Participants With Clinically Significant Vital Sign findings | Blood pressure(mmHg), pulse (beats/min) and body temperature(℃) were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability. | Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II) |
| Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings | Ventricular rate(beats/min), RR, PR interval(msec), QRS duration(msec), QTcB and QTcF were recorded. The results of 12-lead ECG will be categorized Normal/Abnormal NCS(No clinically significant)/Abnormal CS(clinically significant). | Day -2 (Randomization) to Day 54~60 (Post-study visit of Part I) and Day 36~42 (Follow up visit of Part II) |
| Number of Participants With Clinically Significant Laboratory results | Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability. | Day -2 (Randomization) to Day 60 (Post-study visit of Part I) and Day 42 (Follow up visit of Part II) |
| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
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