NCT06337604

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: TenNor Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-10-10
• Primary completion: 2017-11-23
• Completion: 2017-11-23
• First posted: 2024-03-29
• Last updated: 2024-04-01

Locations

1 site across 1 country: China