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

An Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction After Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04066257

Enrollment

Registered

2019-08-26

Start date

2019-01-17

Completion date

2019-04-25

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Drug-Drug interaction, pharmacokinetic

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

Interventions

DRUGTegoprazan

Tegoprazan 50 mg tablet

DRUGMetronidazole

Metronidazole 250 mg tablet

DRUGTetracycline

Tetracycline hydrochloride 250 mg capsule

DRUGBismuth

Tripotassium bismuth dicitrate 300 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026