Trial Outcomes & Findings for Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection (NCT NCT05857163)
NCT ID: NCT05857163
Last Updated: 2025-08-17
Results Overview
The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT.
COMPLETED
PHASE3
700 participants
4 to 6 weeks after the last dose of the study drugs
2025-08-17
Participant Flow
Participant milestones
| Measure |
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, twice daily (BID) for 14 days
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
353
|
347
|
|
Overall Study
COMPLETED
|
337
|
337
|
|
Overall Study
NOT COMPLETED
|
16
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection
Baseline characteristics by cohort
| Measure |
Test Group
n=353 Participants
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
|
Control Group
n=347 Participants
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
|
Total
n=700 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
353 Participants
n=5 Participants
|
347 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 11.18 • n=7 Participants
|
39.4 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
439 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
353 Participants
n=5 Participants
|
347 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
353 participants
n=5 Participants
|
347 participants
n=7 Participants
|
700 participants
n=5 Participants
|
|
Participants with H. pylori infection
|
353 Participants
n=5 Participants
|
347 Participants
n=7 Participants
|
700 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 to 6 weeks after the last dose of the study drugsPopulation: All the participants who have been randomized into groups and received at least one dose of study drugs.
The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT.
Outcome measures
| Measure |
Test Group
n=351 Participants
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
|
Control Group
n=346 Participants
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
|
|---|---|---|
|
Eradication Rate of H.Pylori Infection
|
323 Participants
|
304 Participants
|
SECONDARY outcome
Timeframe: 4 to 6 weeks after the last dose of the study drugsPopulation: Participants who have been randomized into groups and received at least one dose of study drugs.
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)
Outcome measures
| Measure |
Test Group
n=351 Participants
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
|
Control Group
n=346 Participants
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
|
|---|---|---|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Clarithromycin resistant
|
92 Participants
|
105 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Clarithromycin susceptible
|
169 Participants
|
154 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Metronidazole resistant
|
168 Participants
|
182 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Metronidazole susceptible
|
92 Participants
|
77 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Amoxicillin resistant
|
19 Participants
|
24 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Amoxicillin susceptible
|
242 Participants
|
235 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Levofloxacin resistant
|
93 Participants
|
85 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Levofloxacin susceptible
|
167 Participants
|
174 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Clarithromycin & Amoxicillin resistant
|
12 Participants
|
16 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
DR (drug-resistant) defined as resistant to at least one class antibiotics for H. pylori infection
|
221 Participants
|
218 Participants
|
|
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
MDR (multidrug-resistant) resistant to at least two classes of antibiotics for H. pylori infection
|
107 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: up to 4-6 weeks after the last dose of the study drugsPopulation: All the participants who have been randomized into groups and received at least one dose of study drugs.
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.
Outcome measures
| Measure |
Test Group
n=351 Participants
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
|
Control Group
n=346 Participants
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
|
|---|---|---|
|
Safety by Assessment of the Number of Participants With Adverse Events (AEs)
|
131 Participants
|
184 Participants
|
SECONDARY outcome
Timeframe: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 1
|
4.08 h
Interval 1.0 to 5.08
|
—
|
SECONDARY outcome
Timeframe: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 14
|
4.58 h
Interval 1.0 to 5.08
|
—
|
SECONDARY outcome
Timeframe: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 1
|
324 ng/mL
Standard Deviation 145
|
—
|
SECONDARY outcome
Timeframe: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 14
|
504 ng/mL
Standard Deviation 187
|
—
|
SECONDARY outcome
Timeframe: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 1
|
3.25 h
Interval 2.21 to 5.25
|
—
|
SECONDARY outcome
Timeframe: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 14
|
3.05 h
Interval 2.45 to 5.8
|
—
|
SECONDARY outcome
Timeframe: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 1
|
1160 h*ng/mL
Standard Deviation 507
|
—
|
SECONDARY outcome
Timeframe: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 14
|
1950 h*ng/mL
Standard Deviation 737
|
—
|
SECONDARY outcome
Timeframe: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) of Rifasutenizol (TNP-2198) on Day 1
|
1240 h*ng/mL
Standard Deviation 548
|
—
|
SECONDARY outcome
Timeframe: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) of Rifasutenizol (TNP-2198) on Day 14
|
2160 h*ng/mL
Standard Deviation 819
|
—
|
SECONDARY outcome
Timeframe: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 1
|
2010000 mL
Standard Deviation 1200000
|
—
|
SECONDARY outcome
Timeframe: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 14
|
1310000 mL
Standard Deviation 982000
|
—
|
SECONDARY outcome
Timeframe: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 1
|
425000 mL/h
Standard Deviation 298000
|
—
|
SECONDARY outcome
Timeframe: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administrationPopulation: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
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.
Outcome measures
| Measure |
Test Group
n=20 Participants
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
|
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
|
|---|---|---|
|
Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 14
|
252000 mL/h
Standard Deviation 172000
|
—
|
Adverse Events
Test Group
Control Group
Serious adverse events
| Measure |
Test Group
n=351 participants at risk
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
|
Control Group
n=346 participants at risk
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
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/351 • up to 4-6 weeks after the last dose of the study drugs
|
0.29%
1/346 • up to 4-6 weeks after the last dose of the study drugs
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/351 • up to 4-6 weeks after the last dose of the study drugs
|
0.29%
1/346 • up to 4-6 weeks after the last dose of the study drugs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sclerosing pneumocytoma
|
0.28%
1/351 • up to 4-6 weeks after the last dose of the study drugs
|
0.00%
0/346 • up to 4-6 weeks after the last dose of the study drugs
|
|
Gastrointestinal disorders
Haematochezia
|
0.28%
1/351 • up to 4-6 weeks after the last dose of the study drugs
|
0.00%
0/346 • up to 4-6 weeks after the last dose of the study drugs
|
|
Gastrointestinal disorders
Defaecation disorder
|
0.28%
1/351 • up to 4-6 weeks after the last dose of the study drugs
|
0.00%
0/346 • up to 4-6 weeks after the last dose of the study drugs
|
|
Gastrointestinal disorders
Abdominal pain
|
0.28%
1/351 • up to 4-6 weeks after the last dose of the study drugs
|
0.00%
0/346 • up to 4-6 weeks after the last dose of the study drugs
|
Other adverse events
| Measure |
Test Group
n=351 participants at risk
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
|
Control Group
n=346 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
24/351 • up to 4-6 weeks after the last dose of the study drugs
|
5.5%
19/346 • up to 4-6 weeks after the last dose of the study drugs
|
|
Gastrointestinal disorders
Nausea
|
6.3%
22/351 • up to 4-6 weeks after the last dose of the study drugs
|
6.1%
21/346 • up to 4-6 weeks after the last dose of the study drugs
|
|
Nervous system disorders
Dizziness
|
6.0%
21/351 • up to 4-6 weeks after the last dose of the study drugs
|
3.5%
12/346 • up to 4-6 weeks after the last dose of the study drugs
|
|
Nervous system disorders
Dysgeusia
|
4.8%
17/351 • up to 4-6 weeks after the last dose of the study drugs
|
36.1%
125/346 • up to 4-6 weeks after the last dose of the study drugs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER