| Primary | Eradication Rate of H.Pylori Infection | The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT. | All the participants who have been randomized into groups and received at least one dose of study drugs. | Posted | | Count of Participants | | Participants | | 4 to 6 weeks after the last dose of the study drugs | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days | | OG001 | Control Group | Amoxicillin capsules 1 g + Clarithromycin tablets 500 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Bismuth potassium citrate capsules 240 mg + Rifasutenizol placebo capsules, BID for 14 days |
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| Secondary | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Percentage of Participants with Successful Helicobacter Pylori (H.pylori) Eradication in Participants with antibiotic-resistant Strains of H.pylori at Baseline (based on the test results of 13C UBT) | Participants who have been randomized into groups and received at least one dose of study drugs. | Posted | | Count of Participants | | Participants | | 4 to 6 weeks after the last dose of the study drugs | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days | | OG001 | Control Group | Amoxicillin capsules 1 g + Clarithromycin tablets 500 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Bismuth potassium citrate capsules 240 mg + Rifasutenizol placebo capsules, BID for 14 days |
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| Secondary | Safety by Assessment of the Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. | All the participants who have been randomized into groups and received at least one dose of study drugs. | Posted | | Count of Participants | | Participants | | up to 4-6 weeks after the last dose of the study drugs | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days | | OG001 | Control Group | Amoxicillin capsules 1 g + Clarithromycin tablets 500 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Bismuth potassium citrate capsules 240 mg + Rifasutenizol placebo capsules, BID for 14 days |
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| Secondary | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 1 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma pharmacokinetic (PK) parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Median | Full Range | h | | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 14 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Median | Inter-Quartile Range | h | | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 1 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 14 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | ng/mL | | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 1 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Median | Full Range | h | | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 14 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Median | Full Range | h | | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 1 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 14 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) of Rifasutenizol (TNP-2198) on Day 1 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) of Rifasutenizol (TNP-2198) on Day 14 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 1 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | mL | | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 14 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | mL | | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 1 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | mL/h | | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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| Secondary | Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 14 | Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | Posted | | Mean | Standard Deviation | mL/h | | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | | | | ID | Title | Description |
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| OG000 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days |
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