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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants

NCT06081699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-10-13

No results posted yet for this study

Summary

This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in healthy subjects.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

TNP-2198

Oral

DRUG

TNP-2198 Placebo

The placebo for TNP-2198 active drug

Sponsors & Collaborators

  • TenNor Therapeutics (Suzhou) Limited

    lead INDUSTRY

Principal Investigators

  • TenNor Clinical Trials · TenNor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2019-09-18
Completion
2019-09-18
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 NCT06081699 on ClinicalTrials.gov