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Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants

NCT06076694 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-12-12

Study results available
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Summary

This is a single-center, randomized, open-label phase Ic/IIb clinical study to evaluate the efficacy and safety of TNP-2198 capsules, rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules compared with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses in Helicobacter pylori infection-positive population.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

TNP-2198

Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days

DRUG

Rabeprazole Sodium

Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days

DRUG

Amoxicillin

Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days

Sponsors & Collaborators

  • TenNor Therapeutics (Suzhou) Limited

    lead INDUSTRY

Principal Investigators

  • TenNor Clinical Trials · TenNor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-26
Primary Completion
2022-09-20
Completion
2022-09-20
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06076694 on ClinicalTrials.gov