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The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets

NCT06337604 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-01

No results posted yet for this study

Summary

A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

TNP-2092 capsules

TNP-2092 capsules 300 mg twice daily(BID): Taken with 240 mL of warm water 30 minutes (± 5 minutes) after breakfast and dinner, with a 12-hour interval between the two doses. Such administration will last 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses.

DRUG

TNP-2092 capsules placebo

TNP-2092 Capsules Placebo 300 mg BID : Taken with 240 mL of warm water 30 minutes (± 5 minutes) after breakfast and dinner, with a 12-hour interval between the two doses. Such administration will last 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses.

DRUG

Rabeprazole sodium enteric-coated tablets

Rabeprazole sodium enteric-coated tablets (20 mg BID): Taken with 240 mL of warm water 30 minutes (± 5 minutes) before breakfast and dinner for 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses.

Sponsors & Collaborators

  • TenNor Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2017-11-23
Completion
2017-11-23

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 NCT06337604 on ClinicalTrials.gov