Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07294846 | Drug Interaction Study on Linaprazan Glurate Capsules | PHASE1 | COMPLETED | 56 | — | — | Sep 8, 2025 | Dec 15, 2025 | Jan 6, 2026 | 1 | China |
Cmax,ss of of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
AUC0-τ,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
Cav,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
Tmax,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
CLss/F of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
t1/2z of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and t1/2z of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Vz/F of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and Vz/F of Pharmacokinetic Parameters of Bismuth in Part 2 study.
λz of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and λz of Pharmacokinetic Parameters of Bismuth in Part 2 study.
MRT of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.
Cmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.
AUC0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Tmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.
CL/F of Pharmacokinetic Parameters of Bismuth in Part 2 study.
Ae0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.
fe of Pharmacokinetic Parameters of Bismuth in Part 2 study.
CLR of Pharmacokinetic Parameters of Bismuth in Part 2 study.
| Arm | Type | Description |
|---|---|---|
| Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period | EXPERIMENTAL | Glurate Capsules Capsules 50mg, BID, consecutive 7-day dosing per period in Part 1. |
| Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing | EXPERIMENTAL | Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing in part 2. |
| Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing. | EXPERIMENTAL | Esomeprazole Magnesium Enteric-coated Tablets 20mg, BID in Part 2. |
| Name | Type | Description |
|---|---|---|
| Linaprazan Glurate Capsules | DRUG | Linaprazan Glurate capsules |
| Bismuth Potassium Citrate Capsules | DRUG | Bismuth Potassium Citrate Capsules |
| Amoxicillin Capsules | DRUG | Amoxicillin Capsules |
| Clarithromycin tablets | DRUG | Clarithromycin Tablets |
| Esomeprazole Magnesium Enteric-coated Tablets | DRUG | Esomeprazole Magnesium Enteric-coated Tablets |
Inclusion Criteria: 1. Age range: 18 to 55 years old (including 18 and 55); 2. Male weight ≥50.0 kg, female weight ≥45.0 kg; Body Mass Index (BMI) between 19.0 and 26.0 kg/m²(including critical value); BMI=weight/height2 (m2) 3. Part 1 Study and Part 2 Study: Part 1: Subjects must be Helicobact...