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Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of LX22001 for injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX22001 for Injecton | Experimental |
| |
| Tegoprazan tablet | Active Comparator |
| |
| Esomeprazole sodium for injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX22001 for Injeciton | Drug | single dose: 25mg,50mg,100mg,200mg ,intravenous infusion. repeat doses: 50mg,100mg , intravenous infusion,once daily for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 7 days from dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24) | pre-dose to Day1 post-dose | |
| Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) | pre-dose to Day1 post-dose |
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"Inclusion Criteria:
"Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Wang | Contact | +86-183-0186-2205 | liwang15@luoxin.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongyun Wang | Peking Union Medical College | Principal Investigator |
| Hongzhong Liu | Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D064098 | Esomeprazole |
| D007267 | Injections |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Tegoprazan tablet | Drug | 50mg,oral,single dose |
|
| Esomeprazole sodium for injection | Drug | 80 mg intravenous infusion for 30 min followed by a continuous infusion of 8 mg/h for 71.5h |
|
| Maximum Observed Plasma Concentration (Cmax) | pre-dose to Day1 post-dose |
| Terminal elimination half-life(t1/2) | pre-dose to Day1 post-dose |
| Apparent total body clearance (CL) | pre-dose to Day1 post-dose |
| Apparent volume of distribution(Vd) | pre-dose to Day1 post-dose |
| Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State | Day 3 post-dose |
| Cmax at Steady State (Cmax,ss) | Day 3 post-dose |
| Percentage of Time Gastric pH above 4 over 24h | baseline, Day 1 and Day 3 |
| Percentage of Time Gastric pH above 6 over 24h | baseline, Day 1 and Day 3 |
| Mean Gastric pH over 24h | baseline, Day 1 and Day 3 |
| 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 |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |