NCT05194046

Drug-drug Interactions and Safety Among JP-1366, Amoxicillin, and Clarithromycin in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, 3-way Crossover Phase 1 Clinical Trial to Evaluate Drug-drug Interactions and Safety Among JP-1366, Amoxicillin, and Clarithromycin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Onconic Therapeutics Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of coadministration of amoxicillin and clarithromycin on safety, tolerability and pharmacokinetics of JP-1366 in healthy subjects and the effect of JP-1366 on safety, tolerability and pharmacokinetics of amoxicillin and clarithromycin in healthy subjects

Conditions

• Helicobacter Pylori Associated Gastrointestinal Disease

Interventions

Type	Name	Description
DRUG	JP-1366 20mg 1capsule	will be orally administered
DRUG	Amoxicillin 500Mg Cap	Amoxicilin 500Mg 2 capsules will be orally administered
DRUG	Clarithromycin 500Mg Tab	Amoxicilin 500Mg 1 tablet will be orally administered

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-01-16
• Completion: 2021-01-19
• First posted: 2022-01-18
• Last updated: 2022-01-18

Locations

1 site across 1 country: South Korea