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| Name | Class |
|---|---|
| Jiangsu Aosaikang Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of an investigational dexlansoprazole injection after multiple intravenous administration in healthy Chinese adults.
This is a single center, open-label, multiple-dose clinical trial. 5 dosing groups were designed, including 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days, and 30 mg q12h in an active comparator, lansoprazole, treatment arm for 5 days. The study will enroll approximately 70 participants with 14 cases in each group. Participants will make 3 visits to the clinic including 8-day of confinement to the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexlansoprazole Injection | Experimental | 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days |
|
| Lansoprazole Injection | Active Comparator | 30 mg q12h in lansoprazole treatment arm for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole Injection | Drug | 15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage time with the intragastric potential of hydrogen (pH)>4 | Duration of intragastric pH>4 within 24 hours postdose | 24 hours post-dose on Day 5 |
| Percentage time with the intragastric pH>6 | Duration of intragastric pH>6 within 24 hours postdose | 24 hours post-dose on Day 5 |
| The time of the intragastric pH reaching 4 | The time of intragastric pH reaching 4 after the last dose | 12 hours post-dose on Day 5 |
| The time of the intragastric pH reaching 6 | The time of intragastric pH reaching 6 after the last dose | 12 hours post-dose on Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean intragastric pH | Mean intragastric pH | 24 hours post-dose on Day 5 |
| Mean intragastric pH per hour | Mean intragastric pH per hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihua Wu, Doctor | Contact | 86-13819195192 | lihuawu73@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lihua Wu, Doctor | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliated hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31338800 | Derived | Wu L, Liu J, Zheng Y, Zhai Y, Lin M, Wu G, Lv D, Shentu J. Pharmacokinetic/Pharmacodynamic Evaluation of Dexlansoprazole Infusion Injection Compared with Lansoprazole in Healthy Chinese Adults. Clin Drug Investig. 2019 Oct;39(10):953-965. doi: 10.1007/s40261-019-00824-2. |
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| Lansoprazole Injection | Drug | 30 mg q12h for 5 days. |
|
| 24 hours post-dose on Day 5 |
| Percentage time with the intragastric pH>4 during the first 4 hours | Duration of intragastric pH>4 within first 4 hours postdose | 4 hours post-dose on Day 5 |
| Percentage time with the intragastric pH>6 during the first 4 hours | Duration of intragastric pH>6 within first 4 hours postdose | 4 hours post-dose on Day 5 |
| Percentage of the participants with duration time of intragastric pH>4 over 12h | Numbers of participants with duration time of intragastric pH>4 over 12h | 12 hours post-dose on Day 5 |
| Percentage of the participants with duration time of intragastric pH>6 over 12h | Numbers of participants with duration time of intragastric pH>6 over 12h | 12 hours post-dose on Day 5 |
| Cmax on day 1 | Maximum observed plasma concentration for dexlansoprazole | 12 hours post-dose on Day 5 |
| Cmax on day 5 | Maximum observed plasma concentration for dexlansoprazole | 12 hours post-dose on Day 5 |
| Area under the plasma concentration-time curve (AUC) on day 1 | AUC from time 0 to the time of the last quantifiable concentration on day 1 | 12 hours post-dose on Day 5 |
| AUC(0-12h) on day 5 | AUC from time 0 to the time of the last quantifiable concentration on day 5 | 12 hours post-dose on Day 5 |
| AUC(0-inf) on day 1 | AUC from time 0 to extrapolated to infinity on day 1 | 12 hours post-dose on Day 5 |
| AUC(0-inf) on day 5 | AUC from time 0 to extrapolated to infinity on day 5 | 12 hours post-dose on Day 5 |
| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| 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 |
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