Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

• Status: Completed
• Trial end date: 2019-04-25
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the pharmacokinetic interaction between tegoprazan and combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Bismuth; Metronidazole; Tetracycline

Criteria

Inclusion Criteria:

• Healthy adult aged ≥ 19 and < 55 year-old on the day of obtaining the informed consent.

• Body mass index (BMI) ≥ 17.5 kg/m2 and < 28.0 kg/m2 with a body weight ≥ 55 kg at screening.

• H. pylori negative.

Exclusion Criteria:

• Medical History

1. History or evidence of clinically significant disease

2. History of gastrointestinal disease (e.g., esophageal disease such as esophageal achalasia or stenosis, and Crohn's disease) or surgery that may affect the absorption of a drug.

3. History or presence of hypersensitivity to IMPs, components of IMPs, benzimidazoles, imidazole derivatives or tetracycline antibiotics

• Laboratory tests(in blood)

1) Total bilirubin, AST (GOT), ALT (GPT) > 1.5 X upper limit of normal (ULN) at screening

• History of drug/alcohol abuse

• Participated in other study and received investigational product within 3 months prior to the first study dose.

• taken a medication known to substantially induce or inhibit a drug metabolizing enzyme

• Not able to use a medically acceptable contraceptive method throughout the study.