H.Pylori Infection
Conditions
Brief summary
A multi-center, randomized, double-blind, bismuth-containing quadruple active comparator-controlled Phase 3 clinical study to evaluate the efficacy and safety of Rifasutenizol in combination with rabeprazole and amoxicillin in the primary treatment of participants with H. pylori infection using an adaptive design with sample size re-estimation.
Detailed description
Subjects will be randomly assigned to test group or control group at a 1:1 ratio stratified by study site, and will receive Rifasutenizol capsules, rabeprazole sodium enteric-coated tablets, amoxicillin capsules combined with clarithromycin placebo tablets and bismuth potassium citrate placebo capsules (test group), or bismuth-containing quadruple regimen of amoxicillin capsules, clarithromycin tablets, rabeprazole sodium enteric-coated tablets and bismuth potassium citrate capsules combined with Rifasutenizol placebo capsules (control group) for 14 consecutive days. carbon-13 (13C) UBT will be performed 4-6 weeks after the last dose to evaluate the eradication effect of H. pylori.
Interventions
1 g, BID, taken orally within half an hour after breakfast and dinner.
DRUGRifasutenizol capsules
400 mg, BID, taken orally within half an hour after breakfast and dinner.
20 mg, BID, taken orally within half an hour before breakfast and dinner.
DRUGClarithromycin placebo tablets
BID, taken orally within half an hour after breakfast and dinner.
DRUGBismuth potassium citrate placebo capsules
BID, taken orally within half an hour before breakfast and dinner.
500 mg, BID, taken orally within half an hour after breakfast and dinner.
240 mg, BID, taken orally within half an hour before breakfast and dinner.
DRUGRifasutenizol placebo capsules
BID, taken orally within half an hour before breakfast and dinner.
Sponsors
TenNor Therapeutics (Suzhou) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily sign the informed consent form. * Age 18-65 years (inclusive), male or female. * The result of 13C-UBT is positive (≥ 4 Delta Over Baseline), and the infection of H. pylori are confirmed by gastroscopic biopsy histology. * Subjects agree to refrain from taking any antibiotics or traditional Chinese medicines with antibacterial effect, bismuth, and antacids (such as proton pump inhibitor, H2 receptor blocker, P-CAB) other than the study drugs during the Screening Period until the end of the study (Visit 5, i.e., Efficacy Evaluation Visit). * Subjects and their heterosexual partners must agree to have no pregnancy plan and voluntarily take effective contraceptive measures during the trial and for at least 6 months after the end of the study medication. * Willing to follow and able to complete all trial procedures.
Exclusion criteria
* Allergy to any of the study drugs (rabeprazole, amoxicillin, clarithromycin, bismuth potassium citrate), allergic constitution (multiple drug and food allergies); or any contraindication to the use of rifamycin, nitroimidazoles or study drugs. * History of H. pylori eradication therapy (including participation in other clinical trials for H. pylori eradication). * Subjects with confirmed tuberculosis (TB) or Mycobacterium avium complex (MAC) infection or a history of TB or MAC infection. * History of dysphagia or any gastrointestinal disorder affecting drug absorption. * History of obstruction pyloric; or excessive gastric acid secretion (such as Zollinger-Ellison syndrome). * History of gastric cancer. * History of neoplasm malignant within 5 years prior to screening, with the exception of basal cell carcinoma or carcinoma cervix in situ treated without evidence of recurrence. * History of esophageal or gastric surgery, except for simple repair of the perforated ulcer. * History of substance abuse or drug use within 5 years prior to screening. * Alcohol abuse or a history of alcohol abuse within 5 years prior to screening (average weekly consumption of ≥ 14 units of alcohol: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine/Chinese rice wine/rice wine); * Presence of active gastric and/or duodenal ulcer. * Anticoagulant therapy or long-term treatment with nonsteroidal anti-inflammatory drugs. * Treatment with any other investigational new drugs within 4 weeks prior to the Screening Period. * Any prohibited medications or non-drug therapies as specified in the protocol (see Section 10.3). * White blood cell count or neutrophil count below the lower limit of normal range. * Anemia (hemoglobin \< 90 g/L). * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, or serum creatinine above the upper limit of normal range. * Test positive for hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, or microspironema pallidum antibody. * Abnormal ECG with clinical significance. * Female subjects who are pregnant, lactating, or have a positive urine pregnancy result during the Screening Period. * Inability to communicate with the Investigator and to comply with the study requirements. * Other conditions considered inappropriate to participate in this study by the Investigator, e.g., the subject has a history of severe central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine, or hematological diseases, or has clinical manifestations of these diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication Rate of H.Pylori Infection | 4 to 6 weeks after the last dose of the study drugs | The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety by Assessment of the Number of Participants With Adverse Events (AEs) | up to 4-6 weeks after the last dose of the 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. |
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | 4 to 6 weeks after the last dose of the 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) |
| Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 353 |
| 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 | 347 |
| Total | 700 |
Baseline characteristics
| Characteristic | Test Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 353 Participants | 347 Participants | 700 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 11.68 | 39.5 years STANDARD_DEVIATION 11.18 | 39.4 years STANDARD_DEVIATION 11.43 |
| Participants with H. pylori infection | 353 Participants | 347 Participants | 700 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 353 Participants | 347 Participants | 700 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 353 participants | 347 participants | 700 participants |
| Sex: Female, Male Female | 220 Participants | 219 Participants | 439 Participants |
| Sex: Female, Male Male | 133 Participants | 128 Participants | 261 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 351 | 0 / 346 |
| other Total, other adverse events | 65 / 351 | 143 / 346 |
| serious Total, serious adverse events | 2 / 351 | 2 / 346 |
Outcome results
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.
Time frame: 4 to 6 weeks after the last dose of the study drugs
Population: All the participants who have been randomized into groups and received at least one dose of study drugs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group | Eradication Rate of H.Pylori Infection | 323 Participants |
| Control Group | Eradication Rate of H.Pylori Infection | 304 Participants |
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.
Time frame: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | 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
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.
Time frame: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | 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
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.
Time frame: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | 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
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.
Time frame: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | 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
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.
Time frame: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 1 | 425000 mL/h | Standard Deviation 298000 |
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.
Time frame: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 14 | 252000 mL/h | Standard Deviation 172000 |
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)
Time frame: 4 to 6 weeks after the last dose of the study drugs
Population: Participants who have been randomized into groups and received at least one dose of study drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Metronidazole susceptible | 92 Participants |
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Levofloxacin resistant | 93 Participants |
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Metronidazole resistant | 168 Participants |
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Levofloxacin susceptible | 167 Participants |
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Amoxicillin resistant | 19 Participants |
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Clarithromycin & Amoxicillin resistant | 12 Participants |
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Clarithromycin susceptible | 169 Participants |
| Test Group | 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 |
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Amoxicillin susceptible | 242 Participants |
| Test Group | 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 |
| Test Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Clarithromycin resistant | 92 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | MDR (multidrug-resistant) resistant to at least two classes of antibiotics for H. pylori infection | 121 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Clarithromycin resistant | 105 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Clarithromycin susceptible | 154 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Metronidazole resistant | 182 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Metronidazole susceptible | 77 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Amoxicillin resistant | 24 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Amoxicillin susceptible | 235 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Levofloxacin resistant | 85 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Levofloxacin susceptible | 174 Participants |
| Control Group | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Clarithromycin & Amoxicillin resistant | 16 Participants |
| Control Group | 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 | 218 Participants |
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.
Time frame: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Group | Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 1 | 3.25 h |
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.
Time frame: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Group | Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 14 | 3.05 h |
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.
Time frame: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 1 | 324 ng/mL | Standard Deviation 145 |
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.
Time frame: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 14 | 504 ng/mL | Standard Deviation 187 |
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.
Time frame: up to 4-6 weeks after the last dose of the study drugs
Population: All the participants who have been randomized into groups and received at least one dose of study drugs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group | Safety by Assessment of the Number of Participants With Adverse Events (AEs) | 131 Participants |
| Control Group | Safety by Assessment of the Number of Participants With Adverse Events (AEs) | 184 Participants |
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.
Time frame: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Group | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 1 | 4.08 h |
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.
Time frame: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Group | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 14 | 4.58 h |
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.
Time frame: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 1 | 2010000 mL | Standard Deviation 1200000 |
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.
Time frame: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Population: All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 14 | 1310000 mL | Standard Deviation 982000 |