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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Metronidazole; Drug: Tegoprazan; Drug: Tetracycline; Drug: Bismuth

• Registration Number: NCT04066257
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

Detailed Description

A open-label, randomized, multiple dose, two arm, two period, crossover study

Study Timeline

• Study Start: 2019-01-17
• Primary Completion: 2019-02-22
• Study Completion: 2019-04-25
• Status Verified: 2019-08
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-22
• Study First Posted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg	Tetracycline	Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days
Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg	Bismuth	Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days
MTN 500 mg+TCL 500 mg+BIS 300 mg	Metronidazole	Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days
MTN 500 mg+TCL 500 mg+BIS 300 mg	Bismuth	Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days
Tegoprazan 50 mg	Tegoprazan	Oral administration of Tegoprazan 50 mg twice daily for 7 days
Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg	Tegoprazan	Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days
Tegoprazan 50 mg+MTN 500 mg+TCL 500 mg+BIS 300 mg	Metronidazole	Oral administration of Tegoprazan 50 mg twice daily, Metronidazole 500 mg three times daily, and Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days
MTN 500 mg+TCL 500 mg+BIS 300 mg	Tetracycline	Oral administration of Metronidazole 500 mg twice daily, Tetracycline hydrochloride 500 mg \& Tripotassium bismuth dicitrate 300 mg four times daily for 7 days

Primary Outcome Measures

Name	Time	Method
AUC0-12 of tegaprazan and metabolite M1	pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.	Area under the plasma concentration versus time curve of tegoprazan
Cmax of tegaprazan and metabolite M1	pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.	Peak Plasma Concentration of tegoprazan and metabolite M1
AUC0-6 of metronidazole, tetracycline and bismuth	pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.	Area under the plasma concentration versus time curve of metronidazole, tetracycline and bismuth
Cmax of metronidazole, tetracycline and bismuth	pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in period1 ,2.	Peak Plasma Concentration of metronidazole, tetracycline and bismuth

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of